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

NCT ID: NCT04169607

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2021-07-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Intervention Type: 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 .

Interventions

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 .

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Han Yuan

Doctor-in-charge of Anesthetist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37440205 (View on PubMed)

Other Identifiers

XYFY2019-KL168-01

Identifier Type: -

Identifier Source: org_study_id