Postoperative AtelectasisNCT04258202
Ventilator-driven Alveolar Recruitment Maneuver
A study testing Alveolar recruitment maneuver in people with Postoperative Atelectasis and Ventilator Lung, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Postoperative Atelectasis, Ventilator Lung, Atelectasis
- What is being tested?
- Alveolar recruitment maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2020to 8 Oct 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who receive laparoscopic surgery in trendelenberg position
Who cannot join
- Patients who are simultaneously participating in other studies
- Patients who are scheduled to leave the intensive care unit after surgery
- Patients with obstructive or restrictive pattern of Severe or moderate grade on Pulmonary function test
- High risk in cardiovascular events (expected postoperative cardiovascular event > 5%)
- Patients with emphysema confirmed by imaging test
- patients with obesity BMI > 35 kg / m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Ventilator-driven Alveolar Maneuver in Laparoscopic Surgery； Tidal Volume Controlled vs Positive End Expiratory Pressure Controlled Cycling Maneuvers； a Randomized Controlled Study
During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung volume but it remains unknown which method is most effective. The primary aim was to compare the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20 cmH20).
Read the detailed description
General anesthesia promotes the formation of atelectasis, which negatively impacts respiratory function and may be associated with subsequent pulmonary complications. Especially, during laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics, suggesting that performing an Alveolar recruitment maneuvers after intubation, circuit disconnection, position change, intraabdominal gas infiltration.
Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on the anaesthesia machine with the adjustable pressure-limiting valve set to the desired inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when switching back to the ventilator circuit, which results in re-collapse of alveoli. For this reason, investigators try to compare the methods of the ventilator-driven ARM.
- Conditions
- Postoperative Atelectasis, Ventilator Lung, Atelectasis, Recruitment
- Being tested
- Alveolar recruitment maneuver
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitment maneuverOther
The two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O.
| Study group | Role | What they receive |
|---|---|---|
| positive end expiratory pressure group | Experimental | Alveolar recruitment maneuver is performed after intubation, pneumoperitoneum, closure of abdominal fascia. PEEP increased in a stepwise manner from 5 to 20 cmH2O, until plateau pressure 30 cmH2, then 10 breaths. After recruitment, ventilation sets at tidal volume 7 mL/kg with positive end expiratory pressure (PEEP) 5cmH2O. Receives: Other: Alveolar recruitment maneuver |
| tidal volume group | Experimental | Alveolar recruitment maneuver is performed after intubation, pneumoperitoneum, closure of abdominal fascia. Tidal volume increased in steps of 4mL/kg of ideal body weight until plateau pressure 30 cmH2O, then 10 breaths. After recruitment, ventilation sets at tidal volume 7 mL/kg with PEEP 5 cmH2O. Receives: Other: Alveolar recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of Atelectasis volume
electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)
Measured: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary outcomes (5)
the change of lung compliance value
comparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver
Measured: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
the change of arterial blood gas analysis
comparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver
Measured: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
the change of driving pressure value
comparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver
Measured: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
the change of peak pressure value
comparison peak pressure (cmH2O) before/after recruitment maneuver
Measured: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
The difference of atelectasis
atelectasis score by lung ultrasonography (score range 0~36)
Measured: at postoperative 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start2 Mar 2020
- Primary completion30 Sep 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AtelectasisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258202
- Sponsor's protocol ID
- SMC2019-11-117-003
- Status last verified
- Jan 2020
- First submitted
- 2 Feb 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Ventilator-driven Alveolar Maneuver in Laparoscopic Surgery； Tidal Volume Controlled vs Positive End Expiratory Pressure Controlled Cycling Maneuvers； a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04258202
- Acronym / sponsor ID
- SMC2019-11-117-003
- Conditions
- Postoperative Atelectasis, Ventilator Lung, Atelectasis, Recruitment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 6 Feb 2020 (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.
During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung volume but it remains unknown which method is most effective. The primary aim was to compare the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20 cmH20).
Detailed description
General anesthesia promotes the formation of atelectasis, which negatively impacts respiratory function and may be associated with subsequent pulmonary complications. Especially, during laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics, suggesting that performing an Alveolar recruitment maneuvers after intubation, circuit disconnection, position change, intraabdominal gas infiltration.
Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on the anaesthesia machine with the adjustable pressure-limiting valve set to the desired inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when switching back to the ventilator circuit, which results in re-collapse of alveoli. For this reason, investigators try to compare the methods of the ventilator-driven ARM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive end expiratory pressure group | Experimental | Other: Alveolar recruitment maneuverAlveolar recruitment maneuver is performed after intubation, pneumoperitoneum, closure of abdominal fascia. PEEP increased in a stepwise manner from 5 to 20 cmH2O, until plateau pressure 30 cmH2, then 10 breaths. After recruitment, ventilation sets at tidal volume 7 mL/kg with positive end expiratory pressure (PEEP) 5cmH2O. |
| tidal volume group | Experimental | Other: Alveolar recruitment maneuverAlveolar recruitment maneuver is performed after intubation, pneumoperitoneum, closure of abdominal fascia. Tidal volume increased in steps of 4mL/kg of ideal body weight until plateau pressure 30 cmH2O, then 10 breaths. After recruitment, ventilation sets at tidal volume 7 mL/kg with PEEP 5 cmH2O. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who receive laparoscopic surgery in trendelenberg position
Key exclusion criteria (6 listed)
- Patients who are simultaneously participating in other studies
- Patients who are scheduled to leave the intensive care unit after surgery
- Patients with obstructive or restrictive pattern of Severe or moderate grade on Pulmonary function test
- High risk in cardiovascular events (expected postoperative cardiovascular event > 5%)
- Patients with emphysema confirmed by imaging test
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 |
|---|---|---|
| Alveolar recruitment maneuverThe two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O. | Other | positive end expiratory pressure group, tidal volume group |
Primary outcome
the change of Atelectasis volume
Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)
5 secondary outcomes
the change of lung compliance value
Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
the change of arterial blood gas analysis
Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
the change of driving pressure value
Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
the change of peak pressure value
Time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
The difference of atelectasis
Time frame: at postoperative 30 minutes
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 10 Nov 2020.
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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 Alveolar recruitment maneuver in people with Postoperative Atelectasis and Ventilator Lung, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 6 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 10 Nov 2020. 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 South Korea. 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?
the change of Atelectasis volume (time frame: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2020.