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Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound

Primary Purpose

Atelectasis, Postoperative Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stepwise PEEP
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis, Postoperative Pulmonary

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 60) during the study will excluded from the study

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

group A

group B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

efficacy of lung ultrasound in optimizing peep
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
Evaluating the effect of stepwise PEEP approach on the incidence of early postoperative in the first 24 hours atelectasis and oxygenation.

Full Information

First Posted
February 3, 2020
Last Updated
August 19, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04269564
Brief Title
Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound
Official Title
the Use of Intraoperative Bedside Lung Ultrasound in Optimizing "Positive End Expiratory Pressure"PEEP in Patients Undergoing Laparoscopic Bariatric Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
August 18, 2020 (Actual)
Study Completion Date
August 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Postoperative Pulmonary

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
No Intervention
Arm Description
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.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Patients in group B received the standard ventilation protocol with stepwise peep until end of surgery and extubation.
Intervention Type
Device
Intervention Name(s)
stepwise PEEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
efficacy of lung ultrasound in optimizing peep
Description
to evaluate the effect of lung ultrasound in optimizing peep in obese patients undergoing laparoscopic surgeries on the Incidence of intraoperative hypoxia and atlectasis
Time Frame
intraoperative and early postoperative first 24 hours after recovery from anaesthesia
Secondary Outcome Measure Information:
Title
effect on early postoperative oxygenation
Description
Evaluating the effect of stepwise PEEP approach on the incidence of early postoperative in the first 24 hours atelectasis and oxygenation.
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 60) during the study will excluded from the study
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30253139
Citation
Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019 Mar;92:6-10. doi: 10.1016/j.metabol.2018.09.005. Epub 2018 Sep 22.
Results Reference
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PubMed Identifier
29430443
Citation
Lobo B, Hermosa C, Abella A, Gordo F. Electrical impedance tomography. Ann Transl Med. 2018 Jan;6(2):26. doi: 10.21037/atm.2017.12.06.
Results Reference
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PubMed Identifier
27669555
Citation
Monastesse A, Girard F, Massicotte N, Chartrand-Lefebvre C, Girard M. Lung Ultrasonography for the Assessment of Perioperative Atelectasis: A Pilot Feasibility Study. Anesth Analg. 2017 Feb;124(2):494-504. doi: 10.1213/ANE.0000000000001603.
Results Reference
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Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound

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