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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Atelectasis
• Intervention / Treatment: Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of postoperative atelectasis	The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.	60-90 minutes after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulse oxygen	Continuous measurement of 24h pulse oxygen after surgery（%）	24 hours after surgery
PaO2/FiO2 ratio	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)	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).	1 day before surgery(baseline)，1，2，7，30 days after surgery
Mini-Mental score examination (MMSE)	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).	1 day before surgery(baseline)，1，2 days after surgery
Postoperative Complication	including pulmonary and other systematic postoperative complications	1，2，7 days after surgery
Mean arterial pressure	Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3（mmHg）	every 5minutes During Surgery；end of each step during RM and titration strategy
systolic blood pressure	systolic blood pressure measured by invasive arterial blood pressure（mmHg）	every 5minutes During Surgery；end of each step during RM and titration strategy
diastolic blood pressure	diastolic blood pressure measured by invasive arterial blood pressure（mmHg）	every 5minutes During Surgery；end of each step during RM and titration strategy
heart rate	heart rate per minute	every 5minutes During Surgery；end of each step during RM and titration strategy
pulse oxygen	pulse oxygen（%）	every 5minutes During Surgery；end of each step during RM and titration strategy
dynamic compliance	tidal volume/(airway peak pressure - PEEP)（ml/cmH2O）	every 5minutes During Surgery；end of each step during RM and titration strategy
airway plateau pressure	airway plateau pressure is directly showed in the screen of ventilator（cmH2O）	every 5minutes During Surgery；end of each step during RM and titration strategy
airway peak pressure	airway peak pressure is directly showed in the screen of ventilator（cmH2O）	every 5minutes During Surgery；end of each step during RM and titration strategy

Collaborators and Investigators

• Sponsor: Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 16, 2019
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): July 19, 2021

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (ACTUAL): November 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Mechanical ventilation; lung protective ventilation strategy; individualized positive end-expiratory pressure; Laparoscopic bariatric surgery; Anesthetic management; Lung dynamic compliance; Postoperative Atelectasis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: XYFY2019-KL168-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No