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

Sponsor

Xuzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04169607

Collaborator

(none)

Enrollment

Location

Arms

19.1

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Atelectasis	Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery: a Single-center, Double-blind Randomized Controlled Trial

Actual Study Start Date :

Dec 16, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Jul 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: individualized PEEP 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 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 .
Active Comparator: PEEP 8 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 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 .

Arm

Intervention/Treatment

Experimental: individualized PEEP

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

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 .

Active Comparator: PEEP 8

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

Outcome Measures

Primary Outcome Measures

Percentage of postoperative atelectasis [60-90 minutes after extubation]
The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.

Secondary Outcome Measures

pulse oxygen [24 hours after surgery]
Continuous measurement of 24h pulse oxygen 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]
PaO2/FiO2 ratio
Quality of Recovery Score - 40 (QoR-40) [1 day before surgery(baseline)，1，2，7，30 days after surgery]
Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).
Mini-Mental score examination (MMSE) [1 day before surgery(baseline)，1，2 days after surgery]
Mini-Mental score examination [MMSE] used for screening of dementia.The total score on the MMSE ranges from 0 (most severe dementia) to 24 (no dementia).
Postoperative Complication [1，2，7 days after surgery]
including pulmonary and other systematic postoperative complications
Mean arterial pressure [every 5minutes During Surgery；end of each step during RM and titration strategy]
Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3（mmHg）
systolic blood pressure [every 5minutes During Surgery；end of each step during RM and titration strategy]
systolic blood pressure measured by invasive arterial blood pressure（mmHg）
diastolic blood pressure [every 5minutes During Surgery；end of each step during RM and titration strategy]
diastolic blood pressure measured by invasive arterial blood pressure（mmHg）
heart rate [every 5minutes During Surgery；end of each step during RM and titration strategy]
heart rate per minute
pulse oxygen [every 5minutes During Surgery；end of each step during RM and titration strategy]
pulse oxygen（%）
dynamic compliance [every 5minutes During Surgery；end of each step during RM and titration strategy]
tidal volume/(airway peak pressure - PEEP)（ml/cmH2O）
airway plateau pressure [every 5minutes During Surgery；end of each step during RM and titration strategy]
airway plateau pressure is directly showed in the screen of ventilator（cmH2O）
airway peak pressure [every 5minutes During Surgery；end of each step during RM and titration strategy]
airway peak pressure is directly showed in the screen of ventilator（cmH2O）