Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04269564

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lung ultrasound imaging is a promising non-invasive, non-radiant, portable and easy to use tool that as yet to be studied in the intraoperative setting.

in our current study, we are trying to reach the optimum PEEP in laparoscopic bariatric patients to prevent postoperative collapse and atlectasis with simple non-invasive procedure.

Condition or Disease	Intervention/Treatment	Phase
Atelectasis, Postoperative Pulmonary	Device: stepwise PEEP	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

the Use of Intraoperative Bedside Lung Ultrasound in Optimizing "Positive End Expiratory Pressure"PEEP in Patients Undergoing Laparoscopic Bariatric Surgeries

Actual Study Start Date :

Feb 20, 2020

Actual Primary Completion Date :

Aug 18, 2020

Actual Study Completion Date :

Aug 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: group A Group A patients received the standard ventilation protocol as follows: volume-controlled ventilation mode, with VT 6 ml/kg of ideal body weight, inspiratory : expiratory ratio 1 : 2, a PEEP of 4 cmH2O, and respiratory rate 10-12 breaths/min that will be adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mmHg and inspired oxygen fraction of 0.5.
Active Comparator: group B Patients in group B received the standard ventilation protocol with stepwise peep until end of surgery and extubation.	Device: stepwise PEEP a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs. Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery. We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2.

Arm

Intervention/Treatment

No Intervention: group A

Group A patients received the standard ventilation protocol as follows: volume-controlled ventilation mode, with VT 6 ml/kg of ideal body weight, inspiratory : expiratory ratio 1 : 2, a PEEP of 4 cmH2O, and respiratory rate 10-12 breaths/min that will be adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mmHg and inspired oxygen fraction of 0.5.

Active Comparator: group B

Patients in group B received the standard ventilation protocol with stepwise peep until end of surgery and extubation.

Device: stepwise PEEP

a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs. Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery. We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2.

Outcome Measures

Primary Outcome Measures

efficacy of lung ultrasound in optimizing peep [intraoperative and early postoperative first 24 hours after recovery from anaesthesia]
to evaluate the effect of lung ultrasound in optimizing peep in obese patients undergoing laparoscopic surgeries on the Incidence of intraoperative hypoxia and atlectasis

Secondary Outcome Measures

effect on early postoperative oxygenation [24 hours postoperative]
Evaluating the effect of stepwise PEEP approach on the incidence of early postoperative in the first 24 hours atelectasis and oxygenation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

they are between 18 and 65 years of age
BMI more than 35
patients with normal respiratory functions
ASA 1 or 2

Exclusion Criteria:

Previous lung surgery
Bronchial asthma
Contralateral lung bullae 4. Uncompensated cardiac disease (NYHA class 3 or 4) 5. Obstructive or restrictive lung disease 6. Patients on home oxygen therapy 7. Hemodynamic instability and increased intracranial pressure 8. In adittion , any patient who developes hemodynamic instability (MAP <60mmHg) or hypoxia (Po2 less than

during the study will excluded from the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Cairo		Egypt	11562

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

mohamed abdel ghany ali, Anesthesia lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT04269564

Other Study ID Numbers:

MS-263-2019

First Posted:

Feb 17, 2020

Last Update Posted:

Aug 20, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Aug 20, 2020