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NCT Number: NCT04169607

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

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.

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Key information

Conditions

Postoperative Atelectasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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 .

Primary outcomes

  1. Percentage of postoperative atelectasis

    Time frame: 60-90 minutes after extubation

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

Secondary outcomes

  1. pulse oxygen

    Time frame: 24 hours after surgery

    Continuous measurement of 24h pulse oxygen after surgery（%）

  2. PaO2/FiO2 ratio

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

    PaO2/FiO2 ratio

  3. Quality of Recovery Score - 40 (QoR-40)

    Time frame: 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).

  4. Mini-Mental score examination (MMSE)

    Time frame: 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).

  5. Postoperative Complication

    Time frame: 1，2，7 days after surgery

    including pulmonary and other systematic postoperative complications

  6. Mean arterial pressure

    Time frame: 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）

  7. systolic blood pressure

    Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy

    systolic blood pressure measured by invasive arterial blood pressure（mmHg）

  8. diastolic blood pressure

    Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy

    diastolic blood pressure measured by invasive arterial blood pressure（mmHg）

  9. heart rate

    Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy

    heart rate per minute

  10. pulse oxygen

    Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy

    pulse oxygen（%）

  11. dynamic compliance

    Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy

    tidal volume/(airway peak pressure - PEEP)（ml/cmH2O）

  12. airway plateau pressure

    Time frame: 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）

  13. airway peak pressure

    Time frame: 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）

Sponsors and collaborators

Lead sponsor

Xuzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 20, 2019
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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