Oxygen DeficiencyNCT03331471
Alveolar Recruitment Maneuver During Pneumoperitoneum
A study testing alveolar recruitment maneuver and conventional ventilation in people with Oxygen Deficiency, run by Gachon University Gil Medical Center at 2 sites in South Korea.
Trial summary
Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study for comparision of incidence of pulmonary complications after applying alveolar recruitment maneuver during peumoperitoenum for laparoscopic… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- alveolar recruitment maneuver and conventional ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Sep 2017to 30 Nov 2019
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- over 65 years, patients who undergoing elective laparoscopoic colorectal surgery for cancer under general anesthesia. ASA pysical status I or II
- Exclusion Criteria:uncontrolled cardiovascular disease, obstructive pulmonary disorder, acute or chronic inflammatory lesion in lung.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Gachon University Gil Hospital
Incheon
Gachon University Gil Medical Center
Incheon
About this study
Official title: Effect of Alveolar Recruitment Maneuver on Postoprative Pulmonary Complications in the Elderly With Laparoscopic Surgery
Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study for comparision of incidence of pulmonary complications after applying alveolar recruitment maneuver during peumoperitoenum for laparoscopic surgery.
Read the detailed description
Peumopritoneum might increase the pulmonary dead space and deteriorate the pulmonary mechanics. Especially in the eldery, decreased pulmonary function might aggravate negative response to pneumoperitoneum. Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics. Investigator designed this study for comparision of the incidences of pulmonary complications after applying alveolar recruitment maneuver or not during peumoperitoenum for laparoscopic surgery in the elderly patients.
- Conditions
- Oxygen Deficiency
- Being tested
- alveolar recruitment maneuver, conventional ventilation
- Medical subject headings
- Hypoxia
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 ARM
applying alveolar recruitment maneuver using the anesthesia machine
conventional ventilationProcedure or surgery
Also called conventional
conventional ventilation using the anesthesia machine
| Study group | Role | What they receive |
|---|---|---|
| alveolar recruitment maneuver | Active comparator | FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O and applying alveolar recruitment maneuver (PEEP 10 cmH2O for 3 breath - PEEP 15 cmH2O for 3 breath and PEEP 20 cmH2O for 10 breath) immediate before and after pneumoperitoneum Receives: Procedure: alveolar recruitment maneuver |
| conventional ventilation | Experimental | FIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O applying during anesthesia Receives: Procedure: conventional ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung complications
Incidence of lung complications
Measured: 2 days after laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start18 Sep 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen DeficiencyStudies 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
- Model description
- ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
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
- Investigators
- Kyung Cheon Lee, Study chair, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331471
- Sponsor's protocol ID
- 2017-270
- Status last verified
- Feb 2020
- First submitted
- 1 Nov 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alveolar Recruitment Maneuver on Postoprative Pulmonary Complications in the Elderly With Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03331471
- Acronym / sponsor ID
- 2017-270
- Conditions
- Oxygen Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 6 Nov 2017 (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.
Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics and reduce the pulmonary complications. Investigator designed this study for comparision of incidence of pulmonary complications after applying alveolar recruitment maneuver during peumoperitoenum for laparoscopic surgery.
Detailed description
Peumopritoneum might increase the pulmonary dead space and deteriorate the pulmonary mechanics. Especially in the eldery, decreased pulmonary function might aggravate negative response to pneumoperitoneum. Alveolar recruitment maneuver had been reported of improving arterial oxygenation and pulmonary mechanics. Investigator designed this study for comparision of the incidences of pulmonary complications after applying alveolar recruitment maneuver or not during peumoperitoenum for laparoscopic surgery in the elderly patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- ARM group-applying alveolar recruitment maneuver Conventional goup-not applying alveolar recruitment maneuver
| Arm | Type | Receives |
|---|---|---|
| alveolar recruitment maneuver | Active comparator | Procedure: alveolar recruitment maneuverFIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O and applying alveolar recruitment maneuver (PEEP 10 cmH2O for 3 breath - PEEP 15 cmH2O for 3 breath and PEEP 20 cmH2O for 10 breath) immediate before and after pneumoperitoneum |
| conventional ventilation | Experimental | Procedure: conventional ventilationFIO2 0.5, TV 6 ml/kg of ideal body weight, PEEP 5 cmH2O applying during anesthesia |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- over 65 years, patients who undergoing elective laparoscopoic colorectal surgery for cancer under general anesthesia. ASA pysical status I or II
- Exclusion Criteria:uncontrolled cardiovascular disease, obstructive pulmonary disorder, acute or chronic inflammatory lesion in lung.
Key exclusion criteria (0 listed)
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: ARMapplying alveolar recruitment maneuver using the anesthesia machine | Procedure or surgery | alveolar recruitment maneuver |
| conventional ventilationAlso: conventionalconventional ventilation using the anesthesia machine | Procedure or surgery | conventional ventilation |
Primary outcome
lung complications
Time frame: 2 days after laparoscopic surgery
Incidence of lung complications
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 18 Feb 2020.
- Individual participant dataSharing planned: No. not yet decided
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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.
Kyung Cheon Lee study chair
Gachon University Gil Medical Center
2 sites 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 and conventional ventilation in people with Oxygen Deficiency, run by Gachon University Gil Medical Center at 2 sites 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 2 inclusion and 0 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
lung complications (time frame: 2 days after laparoscopic 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 18 Feb 2020.