Pain, PostoperativeNCT04259918
Effect of Alveolar Recruitment Maneuver on Postoperative Pain
A study testing Alveolar recruitment maneuver in people with Pain, Postoperative, run by Gachon University Gil Medical Center.
Trial summary
Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Alveolar recruitment maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2020to 31 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who scheduled for elective bariatric surgery
Who cannot join
- uncontrolled cardio-vascular disease, active pulmonary disorder
About this study
Official title: Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery
Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O
Read the detailed description
After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds
- Conditions
- Pain, Postoperative
- Being tested
- Alveolar recruitment maneuver
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitment maneuverProcedure or surgery
Also called Low pressure alveolar recruitment maneuver, High pressure alveolar recruitment maneuver
Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | no applying alveolar recuritment maneuver Receives: Procedure: Alveolar recruitment maneuver |
| Low ARM | Active comparator | Applying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec Receives: Procedure: Alveolar recruitment maneuver |
| High ARM | Active comparator | Applying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec Receives: Procedure: Alveolar recruitment maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale for postoperative pain
score (0 no pain-10 severe pain)
Measured: up to postoperative 24 hour
Quality of recovery (QoR40) for Postoperative comfort
score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Measured: up to postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start25 Feb 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Yi Jo, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259918
- Sponsor's protocol ID
- Gil2019-1
- Status last verified
- Feb 2020
- First submitted
- 20 Jan 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alveolar Recruitment Maneuver on Postoperative Pain After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04259918
- Acronym / sponsor ID
- Gil2019-1
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 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.
Control group: no additional procedure Low ARM group : recruitment maneuver of 30cmH2O High ARM group: recruitment maneuver of 60cmH2O
Detailed description
After random assignment of group, Control group: no additional procedure apply, Low ARM group : after surgical trocha out after bariatric surgery, applying 30cmH2O recruitment maneuver 5 times every 5 seconds, High ARM group: after surgical trocha out after bariatric surgery, applying 60cmH2O recruitment maneuver 5 times every 5 seconds
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Procedure: Alveolar recruitment maneuverno applying alveolar recuritment maneuver |
| Low ARM | Active comparator | Procedure: Alveolar recruitment maneuverApplying 30 cmH2O of alveolar recruitment maneuver 5 times every 5sec |
| High ARM | Active comparator | Procedure: Alveolar recruitment maneuverApplying 60 cmH2O of alveolar recruitment maneuver 5 times every 5sec |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who scheduled for elective bariatric surgery
Key exclusion criteria (1 listed)
- uncontrolled cardio-vascular disease, active pulmonary disorder
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 maneuverAlso: Low pressure alveolar recruitment maneuver, High pressure alveolar recruitment maneuverApplying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery | Procedure or surgery | Control, High ARM, Low ARM |
Primary outcome
numeric rating scale for postoperative pain
Time frame: up to postoperative 24 hour
score (0 no pain-10 severe pain)
Quality of recovery (QoR40) for Postoperative comfort
Time frame: up to postoperative 24 hour
score 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 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.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar recruitment maneuver in people with Pain, Postoperative, run by Gachon University Gil Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
numeric rating scale for postoperative pain (time frame: up to postoperative 24 hour). The study lists 2 primary outcomes in all. 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 19 Feb 2020.