Atelectasis, Postoperative PulmonaryNCT03943433
Oxygen Concentration During Alveolar Recruitment
A study testing FiO2_1.0 and FiO2_0.4 in people with Atelectasis, Postoperative Pulmonary, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Atelectasis, Postoperative Pulmonary
- What is being tested?
- FiO2_1.0 and FiO2_0.4
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2019to 10 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position
Who cannot join
- American Society of Anesthesiologists physical status IV or more
- Severe cardiovascular disease
- Severe chronic obstructive pulmonary disease, emphysema
- History of pneumothorax, bullae
- History of lung resection surgery
- Conversion to laparotomy
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis
The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.
- Conditions
- Atelectasis, Postoperative Pulmonary
- Being tested
- FiO2_1.0, FiO2_0.4
- Keywords
- Absorption atelectasis, Lung sono, Oxygen concentration
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiO2_1.0Procedure or surgery
Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
FiO2_0.4Procedure or surgery
Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
| Study group | Role | What they receive |
|---|---|---|
| FiO2_1.0 | Active comparator | Alveolar recruitment is performed with 100% oxygen concentration at specific time points. Receives: Procedure: FiO2_1.0 |
| FiO2_0.4 | Experimental | Alveolar recruitment is performed with 40% oxygen concentration at specific time points. Receives: Procedure: FiO2_0.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified lung ultrasound score
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.
Measured: Intraoperative (at the end of operation, before emergence)
Secondary outcomes (5)
Modified lung ultrasound score
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.
Measured: Postoperative 30 minutes
Intraoperative desaturation
Oxygen saturation by pulse oximetry <95%
Measured: Intraoperative
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Measured: Intraoperative (20minutes after each recruitment)
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Measured: Postoperative 30 minutes
Postoperative pulmonary complication
respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start15 May 2019
- Primary completion20 Mar 2020
- Study completion10 Jul 2020
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 Atelectasis, Postoperative PulmonaryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
- Investigators
- Jae-Hyon Bahk, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943433
- Sponsor's protocol ID
- JHBahk_AR
- Status last verified
- Jul 2020
- First submitted
- 7 May 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y.
PubMed 32682397
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis
- ClinicalTrials.gov ID
- NCT03943433
- Acronym / sponsor ID
- JHBahk_AR
- Conditions
- Atelectasis, Postoperative Pulmonary
- Keywords
- Absorption atelectasis, Lung sono, Oxygen concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 9 May 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.
The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FiO2_1.0 | Active comparator | Procedure: FiO2_1.0Alveolar recruitment is performed with 100% oxygen concentration at specific time points. |
| FiO2_0.4 | Experimental | Procedure: FiO2_0.4Alveolar recruitment is performed with 40% oxygen concentration at specific time points. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists physical status IV or more
- Severe cardiovascular disease
- Severe chronic obstructive pulmonary disease, emphysema
- History of pneumothorax, bullae
- History of lung resection surgery
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 |
|---|---|---|
| FiO2_1.0Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation. | Procedure or surgery | FiO2_1.0 |
| FiO2_0.4Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation. | Procedure or surgery | FiO2_0.4 |
Primary outcome
Modified lung ultrasound score
Time frame: Intraoperative (at the end of operation, before emergence)
The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)~3 (severe atelectasis), so the maximum total score is 36.
5 secondary outcomes
Modified lung ultrasound score
Time frame: Postoperative 30 minutes
Intraoperative desaturation
Time frame: Intraoperative
Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time frame: Intraoperative (20minutes after each recruitment)
Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio
Time frame: Postoperative 30 minutes
Postoperative pulmonary complication
Time frame: Postoperative 24 hours
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 14 Jul 2020.
- Derived from this study: PubMed 32682397Kim BR, Lee S, Bae H, Lee M, Bahk JH, Yoon S. Lung ultrasound score to determine the effect of fraction inspired oxygen during alveolar recruitment on absorption atelectasis in laparoscopic surgery: a randomized controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):173. doi: 10.1186/s12871-020-01090-y.
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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.
Jae-Hyon Bahk, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiO2_1.0 and FiO2_0.4 in people with Atelectasis, Postoperative Pulmonary, run by Seoul National University Hospital 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 7 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 14 Jul 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?
Modified lung ultrasound score (time frame: Intraoperative (at the end of operation, before emergence)). 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 NCT03943433, 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 14 Jul 2020.