ObesityNCT01780571
CPAP/PSV Preoxygenation in Obese Patients
A study testing CPAP 5 cm H2O + PSV 5 cm H2O in people with Obesity and Anaesthesia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether continuouse positive airway pressure (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels of oxygen in the blood. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Anaesthesia
- What is being tested?
- CPAP 5 cm H2O + PSV 5 cm H2O
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- May 2009to Dec 2012
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) > 35 kg/m2
- scheduled to undergo elective gastric bypass surgery
- age ≥ 18 years
- ASA Physical Status Classification II-III
Who cannot join
- significant cardiopulmonary disease
- previous abdominal or thoracic surgery
- inability to comprehend the protocol.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Anesthesiology and Intensive Care Danderyd Hospital
Stockholm, 18288
About this study
Official title: Continuous Positive Airway Pressure/Pressure Support Preoxygenation of Morbidly Obese Patients
The purpose of this study is to determine whether continuouse positive airway pressure (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels of oxygen in the blood.
- Conditions
- Obesity, Anaesthesia
- Being tested
- CPAP 5 cm H2O + PSV 5 cm H2O
- Keywords
- Obesity, general anaesthesia, preoxygenation, atelectasis
- Medical subject headings
- Obesity, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP 5 cm H2O + PSV 5 cm H2OProcedure or surgery
Patients in the intervention group received Continuous Positive Airway Pressure (5 cm H2O) and Pressure Supported Ventilation (5 cm H2O)
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Neutral pressure breathing after 2 min preoxygenation |
| Active group | Active comparator | CPAP 5cm H2O + PSV 5cm H2O breathing after 2 min preoxygenation Receives: Procedure: CPAP 5 cm H2O + PSV 5 cm H2O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post intubation PaO2levels
PaO2 levels is measured within 5 minutes after the completion of intubation.
Measured: 5 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Näslund, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780571
- Sponsor's protocol ID
- KIDS CPAP
- Status last verified
- Jan 2013
- First submitted
- 9 Dec 2012
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure/Pressure Support Preoxygenation of Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT01780571
- Acronym / sponsor ID
- KIDS CPAP
- Conditions
- Obesity, Anaesthesia
- Keywords
- Obesity, general anaesthesia, preoxygenation, atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 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.
The purpose of this study is to determine whether continuouse positive airway pressure (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels of oxygen in the blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Neutral pressure breathing after 2 min preoxygenation |
| Active group | Active comparator | Procedure: CPAP 5 cm H2O + PSV 5 cm H2OCPAP 5cm H2O + PSV 5cm H2O breathing after 2 min preoxygenation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- body mass index (BMI) > 35 kg/m2
- scheduled to undergo elective gastric bypass surgery
- age ≥ 18 years
- ASA Physical Status Classification II-III
Key exclusion criteria (3 listed)
- significant cardiopulmonary disease
- previous abdominal or thoracic surgery
- inability to comprehend the protocol.
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 |
|---|---|---|
| CPAP 5 cm H2O + PSV 5 cm H2OPatients in the intervention group received Continuous Positive Airway Pressure (5 cm H2O) and Pressure Supported Ventilation (5 cm H2O) | Procedure or surgery | Active group |
Primary outcome
Post intubation PaO2levels
Time frame: 5 minutes after intubation
PaO2 levels is measured within 5 minutes after the completion of intubation.
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 31 Jan 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP 5 cm H2O + PSV 5 cm H2O in people with Obesity and Anaesthesia, run by Karolinska Institutet 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 3 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 31 Jan 2013. 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?
Post intubation PaO2levels (time frame: 5 minutes after intubation). 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 31 Jan 2013.