Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery

NCT04169607 | Completed

• 1 other identifier: XYFY2019-KL168-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to explore the effect of dynamic compliance guided individualized positive end-expiratory pressure titration strategy on reducing the level of postoperative atelectasis in obese patient who have laparoscopic bariatric surgery.The results of the study are to assess the effects of this intervention on the incidence，duration of postoperative atelectasis and other complications including hypoxemia etc. after laparoscopic bariatric surgery.And reducing the burden of postoperative atelectasis on patients and their families, hospitals and public resources.

Conditions

Postoperative Atelectasis

Keywords

lung protective ventilation strategy; individualized positive end-expiratory pressure; Laparoscopic bariatric surgery; Mechanical ventilation; Anesthetic management; Lung dynamic compliance; Postoperative Atelectasis

Outcome Measures

Primary Outcomes (1)

• Percentage of postoperative atelectasis

  The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.

  60-90 minutes after extubation

Secondary Outcomes (13)

• pulse oxygen

  24 hours after surgery

• PaO2/FiO2 ratio

  1 day before surgery(baseline)，5 minutes after anesthesia induction，1 hour after pneumoperitoneum，before extubation，30 minutes after extubation

• Quality of Recovery Score - 40 (QoR-40)

  1 day before surgery(baseline)，1，2，7，30 days after surgery

• Mini-Mental score examination (MMSE)

  1 day before surgery(baseline)，1，2 days after surgery

• Postoperative Complication

  1，2，7 days after surgery

Study Arms (2)

individualized PEEP

EXPERIMENTAL

Basic ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized, the PEEP was then maintained (individualized PEEP arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.

Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

PEEP 8

ACTIVE COMPARATOR

Bacis ventilation: Volume-controlled ventilation mode with positive end-expiratory pressure（PEEP） of 8cm H2O after induction of anesthesia， Recruitment maneuver: Pressure-controlled ventilation mode increasing PEEP from 10 to 25cmH2O. PEEP-titration maneuver: At this PEEP level, a decremental PEEP-titration maneuver will be started in volume-controlled ventilation mode, decreasing PEEP to 5cmH2O to confirm the highest dynamic lung compliance. After titration: A new recruitment maneuver will be performed and the final PEEP will be the one related to the highest dynamic lung compliance plus 2cm H2O. Randomization: Subsequently patient was randomized , the PEEP was then reduced to 8cm H2O (PEEP8 arm) until extubation. After discharged from post-anesthesia care unit (60 to 90 minutes after extubation)：A chest computerized tomography（CT） will be performed to assess the amount of atelectasis, expressed as the percentage of lung tissue in CT.

Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Interventions

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy PROCEDURE

Basic ventilation: Volume-controlled ventilation (VCV) mode with positive end-expiratory pressure (PEEP) of 8cm H2O after induction of anesthesia， Recruitment maneuver (RM): Pressure-controlled ventilation (PCV) mode increasing PEEP from 10 to 25cmH2O in step of 5cmH2O per 30s. PEEP-titration maneuver: ventilation parameters reset as basic ventilation with PEEP still 25cmH2O.Decrease PEEP to 5cmH2O in step of 2cmH2O per 10 respiratory cycles to confirm the highest dynamic lung compliance (Cdy). After titration: A new RM will be performed and the final PEEP will be the one related to highest Cdy plus 2cm H2O. Randomized after the second RM. Individualized PEEP arm: maintain individualized PEEP; PEEP8 arm: maintain a fixed PEEP of 8cm H2O. VCV with other ventilation parameters the same as basic ventilation until extubation . After discharged from postoperative anesthesia care unit (60 to 90 minutes after extubation): chest CT .

PEEP 8; individualized PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bmi ≥ 35 kg/ m2
• over 18 years old
• elective laparoscopic bariatric surgery (gastric bypass or sleeve)

You may not qualify if:

• ASA \>IV
• Lung bullae
• thoracic surgery history
• quit smoking less than 1 week
• chronic obstructive pulmonary disease requiring oxygen
• congestive heart failure (New York Heart Association classification ≥ III)
• planned to be transferred to intensive care unit after surgery
• Patients participating in another interventional study
• Refuse to sign the informed consent

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Related Publications (1)

• Li X, Liu H, Wang J, Ni ZL, Liu ZX, Jiao JL, Han Y, Cao JL. Individualized Positive End-expiratory Pressure on Postoperative Atelectasis in Patients with Obesity: A Randomized Controlled Clinical Trial. Anesthesiology. 2023 Sep 1;139(3):262-273. doi: 10.1097/ALN.0000000000004603.

  PMID: 37440205 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-in-charge of Anesthetist

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: November 20, 2019
• Study Start: December 16, 2019
• Primary Completion: September 30, 2020
• Study Completion: July 19, 2021
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

CN (1)