Optimizing PEEP in Laparoscopic Bariatric Surgery Using Bedside Lung Ultrasound

Atelectasis, Postoperative Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269564
• Other study ID #: MS-263-2019
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: August 19, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 19, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis, Postoperative Pulmonary
• Pulmonary Atelectasis

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraoperative and early postoperative first 24 hours after recovery from anaesthesia
Secondary	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.	24 hours postoperative