Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?

Sponsor
Mansoura University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04872361
Collaborator
(none)
117
1
3
17
6.9

Study Details

Study Description

Brief Summary

Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation.

Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Low PEEP
  • Procedure: High PEEP
  • Procedure: High PEEP/RM
  • Device: Lung ultrasonogrphy assessment
N/A

Detailed Description

The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography.

Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries.

A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography

Study Design

Study Type:
Interventional
Anticipated Enrollment :
117 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double-blind (Participant, Outcomes Assessor).
Primary Purpose:
Prevention
Official Title:
Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Low PEEP

Low positive end-expiratory pressure (PEEP) and no recruitment maneuver (RM)

Procedure: Low PEEP
Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study

Device: Lung ultrasonogrphy assessment
The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines three or more B lines coalescent B lines consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss

Active Comparator: High PEEP

High positive end-expiratory pressure (PEEP)

Procedure: High PEEP
PEEP of 10 cm H2O will be applied

Device: Lung ultrasonogrphy assessment
The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines three or more B lines coalescent B lines consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss

Active Comparator: High PEEP/RM

High positive end-expiratory pressure (PEEP) and recruitment maneuver (RM)

Procedure: High PEEP/RM
PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence

Device: Lung ultrasonogrphy assessment
The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines three or more B lines coalescent B lines consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss

Outcome Measures

Primary Outcome Measures

  1. Pre-emergence LUS score [intraoperative before recovery from anesthesia]

    Lung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.

Secondary Outcome Measures

  1. Lung ultrasonography score (LUS score) [preoperative, intraoperative for anesthesia duration to 1 hour postoperative]

    Lung ultrasonography score (LUS score) between groups

  2. Heart rate [preoperative, intraoperative for anesthesia duration to 1 hour postoperative]

    heart rate between groups at each time point of LUS score performance

  3. Mean blood pressure [preoperative, intraoperative to 1 hour postoperative]

    mean arterial blood pressure between groups at each time point of LUS score performance

  4. oxygen saturation [preoperative, intraoperative to 1 hour postoperative]

    patient oxygen saturation between groups at each time point of LUS score performance

  5. End-tidal carbon dioxide tension [intraoperative for anesthesia duration]

    end tidal CO2 between groups post induction, post recruitment and before extubation

  6. Arterial partial pressure of oxygen (PaO2) [Intraoperative and 15 min postoperative]

    arterial blood gases post induction, before extubation and at the PACU

  7. Arterial partial pressure of carbon dioxide (PaCO2) [Intraoperative and 15 min postoperative]

    arterial blood gases post induction, before extubation and at the PACU

  8. PaO2/FiO2 [Intraoperative and 15 min postoperative]

    arterial blood gases post induction, before extubation and at the PACU

  9. Peak inspiratory pressure [intraoperative for anesthesia duration]

    peak inspiratory pressure between groups after intubation

  10. Postoperative pulmonary complications (PPCs) [5 days]

    PPCs include (pneumothorax, pleural effusion, pulmonary collapse, atelectasis, pneumonia, acute respiratory distress syndrome (ARDS), or pulmonary aspiration).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • American Society of Anesthesiologists' physical status grades I, II, and III.
Exclusion Criteria:
  • Patient refusal.

  • Psychiatric diseases.

  • Body Mass Index > 35 Kg/m2.

  • Previous intrathoracic procedures.

  • History of severe obstructive pulmonary disease.

  • History of severe restrictive lung disease.

  • Pulmonary arterial hypertension ( systolic pulmonary arterial pressure >40 mmHg).

  • Pregnancy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Mansoura DK Egypt 050

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Study Chair: Aboelnour E Badran, MD, Professor of Anesthesia and Surgical Intensive Care
  • Study Director: Hanaa M EL- Bendary, MD, Assistant Professor of Anesthesia and Surgical Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT04872361
Other Study ID Numbers:
  • MFM-IRB.MD.21.01.412
First Posted:
May 4, 2021
Last Update Posted:
May 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2021