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

X

Xuzhou Medical University

Status

Completed

Conditions

Postoperative Atelectasis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04169607
XYFY2019-KL168-01

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

individualized PEEP
Experimental group
Description:
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.
Treatment:
Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy
PEEP 8
Active Comparator group
Description:
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.
Treatment:
Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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