Focus of Study is Postoperative Pulmonary AtelectacisNCT01779076
Oxygen Level and Safe Emergence From Anesthesia
A study testing 30% oxygen and 100% oxygen in people with Focus of Study is Postoperative Pulmonary Atelectacis, run by Region Västmanland at 1 site in Sweden.
Trial summary
Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Focus of Study is Postoperative Pulmonary Atelectacis
- What is being tested?
- 30% oxygen and 100% oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to 11 Jun 2013
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No sign of difficult airway or intubation
- Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
- Body mass index less than 35.
- American Society of Anesthesiologists physical status (ASA) class I-III
Who cannot join
- Body mass index 35 or higher
- Increased risk of aspiration
- Obstructive sleep apnea syndrome
- Procedures during surgery making a former easy airway a difficult airway
- Need for opioids after extubation
- Hypothermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.
Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.
- Being tested
- 30% oxygen, 100% oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% oxygenProcedure or surgery
100% oxygenProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 100% oxygen during extubation | Experimental | In this arm the intervention will consist of 100 % oxygen. Receives: Procedure: 100% oxygen |
| 30% oxygen during extubation | Experimental | In this arm the intervention will consist of 30 % oxygen. Receives: Procedure: 30% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of atelectasis
The area of atelectasis is investigated by computed tomography of the lungs postoperatively
Measured: 30 minutes
Secondary outcomes (1)
Peripheral oxygen saturation (SpO2)
SpO2 is continuously assessed postoperatively.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completion11 Jun 2013
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 Focus of Study is Postoperative Pulmonary AtelectacisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennart Edmark, Region Västmanland
- Investigators
- Mats Enlund, M.D., Ph.D., Principal investigator, Landstinget i Värmland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779076
- Sponsor's protocol ID
- Dnr 2012 / 539
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Edmark L, Auner U, Lindback J, Enlund M, Hedenstierna G. Post-operative atelectasis - a randomised trial investigating a ventilatory strategy and low oxygen fraction during recovery. Acta Anaesthesiol Scand. 2014 Jul;58(6):681-8. doi: 10.1111/aas.12322. Epub 2014 Apr 11.
PubMed 24720763
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.
- ClinicalTrials.gov ID
- NCT01779076
- Acronym / sponsor ID
- Dnr 2012 / 539
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- 11 Jun 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- 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.
Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100% oxygen during extubation | Experimental | Procedure: 100% oxygenIn this arm the intervention will consist of 100 % oxygen. |
| 30% oxygen during extubation | Experimental | Procedure: 30% oxygenIn this arm the intervention will consist of 30 % oxygen. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No sign of difficult airway or intubation
- Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
- Body mass index less than 35.
- American Society of Anesthesiologists physical status (ASA) class I-III
Key exclusion criteria (6 listed)
- Body mass index 35 or higher
- Increased risk of aspiration
- Obstructive sleep apnea syndrome
- Procedures during surgery making a former easy airway a difficult airway
- Need for opioids after extubation
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 |
|---|---|---|
| 30% oxygen | Procedure or surgery | 30% oxygen during extubation |
| 100% oxygen | Procedure or surgery | 100% oxygen during extubation |
Primary outcome
Area of atelectasis
Time frame: 30 minutes
The area of atelectasis is investigated by computed tomography of the lungs postoperatively
1 secondary outcome
Peripheral oxygen saturation (SpO2)
Time frame: 3 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 17 Jan 2018.
- Derived from this study: PubMed 24720763Edmark L, Auner U, Lindback J, Enlund M, Hedenstierna G. Post-operative atelectasis - a randomised trial investigating a ventilatory strategy and low oxygen fraction during recovery. Acta Anaesthesiol Scand. 2014 Jul;58(6):681-8. doi: 10.1111/aas.12322. Epub 2014 Apr 11.
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.
Mats Enlund, M.D., Ph.D. principal investigator
Landstinget i Värmland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30% oxygen and 100% oxygen in people with Focus of Study is Postoperative Pulmonary Atelectacis, run by Region Västmanland at 1 site in Sweden.
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 4 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 17 Jan 2018. 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 Sweden. 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?
Area of atelectasis (time frame: 30 minutes). 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 NCT01779076, 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 17 Jan 2018.