Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients

• Sponsor: Sri Aurobindo Institute of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03024658
• Collaborator: (none)
• Enrollment: 70
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

Brief Summary

Background: Positive end expiratory pressure (PEEP) at the time of induction increases oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all cases. Factors affecting the action of PEEP have not been elucidated well and remain controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured by trans-thoracic echocardiography.

Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated in the study. Thirty patients received no PEEP at the time of induction while other 30 patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at the time of intubation, 5 min after intubation and 10 min after intubation. Patients were then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP or > 30 mm Hg

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Other: positive end expiratory pressure (PEEP)	N/A

Detailed Description

This prospective study was conducted in the Department Of Anaesthesiology& Critical Care, Sri Aurobindo Institute of Medical Sciences & P.G. Institute and Mohak Hospitals, Indore, over a period of one year. Seventy morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery were selected and a written informed consent was obtained. All the recruited patients underwent 2D-trans-thoracic echocardiography and PASP was recorded. Echocardiography was performed by same cardiologist as this measurement is operator dependent. Patients who denied consent, those undergoing Emergency and/or open surgery and those requiring more than 2 attempts for intubation were excluded.

Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter recording done while the patient was breathing room air. Both groups were pre-oxygenated for 3 minutes with 100% Oxygen. Standard procedure was used for induction of anesthesia in all the patients. No premedication was given. All the patients were induced with i.v. Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1- 1.5 mg/ kg. Mechanical ventilation was started with 100% oxygen. A PEEP of 10 cm H2O was applied using four hand technique in Study group while the control group received no PEEP. After one minute endotracheal intubation was done. PEEP was continued in study group after intubation.

Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following stages:

1. Just after inflation of cuff of endotracheal tube

2. 5 minutes post intubation

3. 10 minutes post intubation

Patients were then again divided into four groups on the basis of PASP:

Group 1: Patients with PASP ≤ 30 mmHg receiving no PEEP (n= 11) Group 2: PASP ≤ 30 mm Hg receiving PEEP of 10 cm H2O (n= 11) Group 3: PASP > 30 mm Hg receiving no PEEP (n= 19) Group 4: PASP > 30 mm Hg receiving PEEP of 10 cm H2O (n=19)

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Zero PEEP This group of patients did not receive any PEEP at the time of induction of general anesthesia (n= 30)
Experimental: PEEP- 10 cm of H2O This group comprised of patients who received a PEEP of 10 cm H2O at the time of induction of general anesthesia (n= 30)	Other: positive end expiratory pressure (PEEP); Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery

Outcome Measures

Primary Outcome Measures

1. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value]

   Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

2. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia [Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value]

   Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

3. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia [Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value]

   Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

4. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia [Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value]

   Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

5. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia [Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value]

   Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

6. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube]

   Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

7. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube]

   Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

8. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube]

   Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

9. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube]

   Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

10. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube]

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

11. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation]

    Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

12. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation]

    Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

13. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Pulse rate (beats/ min) was recorded five minutes post intubation]

    Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

14. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Systolic BP in mm Hg was recorded five minutes post intubation]

    Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

15. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Diastolic BP in mm Hg was recorded five minutes post intubation]

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

16. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation]

    Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

17. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation]

    Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

18. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [pulse Rate (beats/ min) was recorded ten minutes post intubation]

    Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

19. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Systolic BP in mm Hg was recorded ten minutes post intubation]

    Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

20. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction [Diastolic BP in mm Hg was recorded ten minutes post intubation]

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

Secondary Outcome Measures

1. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value]

   Preoperative arterial oxygenation was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

2. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value]

   Preoperative arterial carbon di oxide was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

3. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value]

   Preoperative pulse rate was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

4. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value]

   Systolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

5. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value]

   Diastolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

6. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube]

   Arterial oxygenation recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

7. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube]

   Arterial carbon di oxide (mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

8. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube]

   Pulse rate (beats/ min) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameters was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

9. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube]

   Systolic pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

10. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube]

    Diastolic blood pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

11. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded five minutes post intubation]

    Arterial oxygenation recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

12. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded five minutes post intubation]

    Arterial carbon di oxide (mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

13. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded five minutes post intubation]

    Pulse rate (beats/ min) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

14. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded five minutes post intubation]

    Systolic pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

15. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded five minutes post intubation]

    Diastolic blood pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

16. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded ten minutes post intubation]

    Arterial oxygenation (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

17. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded ten minutes post intubation]

    Arterial carbon di oxide (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

18. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded ten minutes post intubation]

    Pulse rate (beats/ min) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

19. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded ten minutes post intubation]

    Systolic blood pressure (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

20. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters [ABG and hemodynamic parameters were recorded ten minutes post intubation]

    Diastolic blood pressure(mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Patients recruited were

• Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,

• Aged 20-65 years

• BMI > 40kg/m2

• scheduled for elective laparoscopic bariatric surgery

Exclusion Criteria:

• Patients who denied consent

• Did not fulfill the inclusion criteria,

• patients undergoing Emergency and/or open surgery

• Patients requiring more than 2 attempts for intubation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sri Aurobindo Institute of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Fredén F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.

• Responsible Party: Dr. Dipti Saxena, Associate Professor, Anaesthesiology, Sri Aurobindo Institute of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03024658
• Other Study ID Numbers: Saims/IEC/14/02/35
• First Posted: Jan 19, 2017
• Last Update Posted: Jan 19, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Dr. Dipti Saxena, Associate Professor, Anaesthesiology, Sri Aurobindo Institute of Medical Sciences: Pulmonary artery systolic pressure; Positive end expiratory pressure; morbidly obese; laparoscopic bariatric surgery
• Additional relevant MeSH terms: Obesity, Morbid

Study Results

No Results Posted as of Jan 19, 2017