Postoperative AtelectasisNCT04169607
Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery
A study testing Dynamic compliance guided individualized positive end-expiratory pressure titration strategy in people with Postoperative Atelectasis, run by Xuzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Atelectasis
- What is being tested?
- Dynamic compliance guided individualized positive end-expiratory pressure titration strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2019to 19 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bmi ≥ 35 kg/ m2
- over 18 years old
- elective laparoscopic bariatric surgery (gastric bypass or sleeve)
Who cannot join
- 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)
Show all 9Show fewer
- planned to be transferred to intensive care unit after surgery
- Patients participating in another interventional study
- Refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
About this study
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
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
- Being tested
- Dynamic compliance guided individualized positive end-expiratory pressure titration strategy
- Keywords
- lung protective ventilation strategy, individualized positive end-expiratory pressure, Laparoscopic bariatric surgery, Mechanical ventilation, Anesthetic management, Lung dynamic compliance, Postoperative Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic compliance guided individualized positive end-expiratory pressure titration strategyProcedure or surgery
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 .
| Study group | Role | What they receive |
|---|---|---|
| individualized PEEP | Experimental | 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. Receives: Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy |
| PEEP 8 | Active comparator | 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. Receives: Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of postoperative atelectasis
The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.
Measured: 60-90 minutes after extubation
Secondary outcomes (13)
pulse oxygen
Continuous measurement of 24h pulse oxygen after surgery（%）
Measured: 24 hours after surgery
PaO2/FiO2 ratio
PaO2/FiO2 ratio
Measured: 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).
Measured: 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).
Measured: 1 day before surgery(baseline)，1，2 days after surgery
Postoperative Complication
including pulmonary and other systematic postoperative complications
Measured: 1，2，7 days after surgery
Mean arterial pressure
Mean arterial pressure = (systolic blood pressure + 2 × diastolic blood pressure) / 3（mmHg）
Measured: 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）
Measured: 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）
Measured: every 5minutes During Surgery；end of each step during RM and titration strategy
heart rate
heart rate per minute
Measured: every 5minutes During Surgery；end of each step during RM and titration strategy
pulse oxygen
pulse oxygen（%）
Measured: every 5minutes During Surgery；end of each step during RM and titration strategy
dynamic compliance
tidal volume/(airway peak pressure - PEEP)（ml/cmH2O）
Measured: 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）
Measured: 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）
Measured: every 5minutes During Surgery；end of each step during RM and titration strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start16 Dec 2019
- Primary completion30 Sep 2020
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169607
- Sponsor's protocol ID
- XYFY2019-KL168-01
- Status last verified
- Jul 2021
- First submitted
- 13 Oct 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37440205
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04169607
- Acronym / sponsor ID
- XYFY2019-KL168-01
- Conditions
- Postoperative Atelectasis
- Keywords
- lung protective ventilation strategy, individualized positive end-expiratory pressure, Laparoscopic bariatric surgery, Mechanical ventilation, Anesthetic management, Lung dynamic compliance, Postoperative Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized PEEP | Experimental | Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategyBasic 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. |
| PEEP 8 | Active comparator | Procedure: Dynamic compliance guided individualized positive end-expiratory pressure titration strategyBacis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bmi ≥ 35 kg/ m2
- over 18 years old
- elective laparoscopic bariatric surgery (gastric bypass or sleeve)
Key exclusion criteria (9 listed)
- ASA >IV
- Lung bullae
- thoracic surgery history
- quit smoking less than 1 week
- chronic obstructive pulmonary disease requiring oxygen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic compliance guided individualized positive end-expiratory pressure titration strategyBasic 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 . | Procedure or surgery | PEEP 8, individualized PEEP |
Primary outcome
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.
13 secondary outcomes
pulse oxygen
Time frame: 24 hours after surgery
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
Quality of Recovery Score - 40 (QoR-40)
Time frame: 1 day before surgery(baseline)，1，2，7，30 days after surgery
Mini-Mental score examination (MMSE)
Time frame: 1 day before surgery(baseline)，1，2 days after surgery
Postoperative Complication
Time frame: 1，2，7 days after surgery
Mean arterial pressure
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
systolic blood pressure
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
diastolic blood pressure
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
heart rate
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
pulse oxygen
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
dynamic compliance
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
airway plateau pressure
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
airway peak pressure
Time frame: every 5minutes During Surgery；end of each step during RM and titration strategy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Derived from this study: PubMed 37440205Li 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.
Related trials for Postoperative Atelectasis
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Enrolling by invitation
Evaluation of the Effectiveness of Lung-Protective Ventilation in Patients Undergoing Laparoscopic Gastrectomy
Postoperative Pulmonary Complications (PPCs), Atelectasis
Not yet recruiting
Flow-Controlled vs. Pressure-Controlled Ventilation in CABG: Effects on Lung Aeration and Diaphragm Function
Coronary Artery Disease, Postoperative Pulmonary Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic compliance guided individualized positive end-expiratory pressure titration strategy in people with Postoperative Atelectasis, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of postoperative atelectasis (time frame: 60-90 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.