Pulmonary AtelectasisNCT01911923
Ventilation Strategy Reduces Postoperative Atelectasis
A study testing No CPAP/PEEP and 100 % oxygen and CPAP/PEEP and 30 % oxygen in people with Pulmonary Atelectasis, run by Region Västmanland at 1 site in Sweden.
Trial summary
Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- No CPAP/PEEP and 100 % oxygen and CPAP/PEEP and 30 % oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Nov 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients up to 75 years of age.
- American Society of Anesthesiologists (ASA) physical status class I-III.
- Be able to climb two flight of stairs without stopping.
- SpO2 of ≥ 94% when breathing air in the supine position.
- A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of < 31.
Who cannot join
- Patients with chronic obstructive pulmonary disease.
- Smokers.
- Ex smokers if smoked more than 5 pack years.
- Overt heart failure
- Known or predicted difficult intubation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.
Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis.
Read the detailed description
During general anesthesia, the combination of reduced functional residual capacity (FRC), high inspiratory oxygen fraction (FIO2), and airway closure are the main factors implicated in the atelectasis, shunt and shunt-like effects that account for the majority of the impaired oxygenation seen during general anesthesia.
Previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (CPAP) followed by a positive end-expiratory pressure (PEEP).During emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. Even a recruitment maneuver, followed by ventilation with 100% oxygen with a PEEP/CPAP of 10 cm H2O until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (ZEEP).This failure may have been caused by the presence of lung regions with high oxygen concentrations.
The investigators hypothesized that by inducing and discontinuing anesthesia during CPAP/PEEP and deliberately reducing FIO2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. To test our hypothesis, the investigators studied 1) a control group with no CPAP/PEEP and a FIO2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on CPAP/PEEP of 6 cmH2O from induction to extubation and that received an FIO2 of 1.0 until extubation and then an FIO2 of 0.3 via a facemask while on CPAP after extubation.
- Conditions
- Pulmonary Atelectasis
- Being tested
- No CPAP/PEEP and 100 % oxygen, CPAP/PEEP and 30 % oxygen
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No CPAP/PEEP and 100 % oxygenProcedure or surgery
This is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled.
CPAP/PEEP and 30 % oxygenProcedure or surgery
During all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used.
| Study group | Role | What they receive |
|---|---|---|
| No CPAP/PEEP and 100 % oxygen | Active comparator | This is the control group Receives: Procedure: No CPAP/PEEP and 100 % oxygen |
| CPAP/PEEP and 30 % oxygen | Experimental | This is the intervention group Receives: Procedure: CPAP/PEEP and 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 assessed immediately after extubation and then continuously postoperatively
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennart Edmark, Region Västmanland
- Investigators
- Lennart Edmark, Md, Principal investigator, Landstinget Vastmaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911923
- Sponsor's protocol ID
- Dnr 2008 / 251
- Status last verified
- Aug 2014
- First submitted
- 26 Jul 2013
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.
- ClinicalTrials.gov ID
- NCT01911923
- Acronym / sponsor ID
- Dnr 2008 / 251
- Conditions
- Pulmonary Atelectasis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 30 Jul 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.
Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis.
Detailed description
During general anesthesia, the combination of reduced functional residual capacity (FRC), high inspiratory oxygen fraction (FIO2), and airway closure are the main factors implicated in the atelectasis, shunt and shunt-like effects that account for the majority of the impaired oxygenation seen during general anesthesia.
Previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (CPAP) followed by a positive end-expiratory pressure (PEEP).During emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. Even a recruitment maneuver, followed by ventilation with 100% oxygen with a PEEP/CPAP of 10 cm H2O until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (ZEEP).This failure may have been caused by the presence of lung regions with high oxygen concentrations.
The investigators hypothesized that by inducing and discontinuing anesthesia during CPAP/PEEP and deliberately reducing FIO2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. To test our hypothesis, the investigators studied 1) a control group with no CPAP/PEEP and a FIO2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on CPAP/PEEP of 6 cmH2O from induction to extubation and that received an FIO2 of 1.0 until extubation and then an FIO2 of 0.3 via a facemask while on CPAP after extubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No CPAP/PEEP and 100 % oxygen | Active comparator | Procedure: No CPAP/PEEP and 100 % oxygenThis is the control group |
| CPAP/PEEP and 30 % oxygen | Experimental | Procedure: CPAP/PEEP and 30 % oxygenThis is the intervention group |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients up to 75 years of age.
- American Society of Anesthesiologists (ASA) physical status class I-III.
- Be able to climb two flight of stairs without stopping.
- SpO2 of ≥ 94% when breathing air in the supine position.
- A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of < 31.
Key exclusion criteria (5 listed)
- Patients with chronic obstructive pulmonary disease.
- Smokers.
- Ex smokers if smoked more than 5 pack years.
- Overt heart failure
- Known or predicted difficult intubation.
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 |
|---|---|---|
| No CPAP/PEEP and 100 % oxygenThis is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled. | Procedure or surgery | No CPAP/PEEP and 100 % oxygen |
| CPAP/PEEP and 30 % oxygenDuring all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used. | Procedure or surgery | CPAP/PEEP and 30 % oxygen |
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: 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2014.
Related trials for Pulmonary Atelectasis
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
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.
Lennart Edmark, Md principal investigator
Landstinget Vastmaland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No CPAP/PEEP and 100 % oxygen and CPAP/PEEP and 30 % oxygen in people with Pulmonary Atelectasis, 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Aug 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 26 Aug 2014.