Respiratory FailureNCT00526981
Prone Position for Non-intubated Patients With Acute Respiratory Failure
A study testing Prone position in people with Respiratory Failure, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral pulmonary infiltrates or unilateral infiltrates involving more than one lobe on CXR
- PaO2/FIO2 < 40 kPa
- RR > 25, or attending intensivist considering likelihood of intubation > 50%
Who cannot join
- unsuited for the prone position
- fulfilled inclusion criteria for more than 5 days (120 h)
- immunosuppression
- chronic lung disease
- decision of withdrawal or limitation of therapy
- pulmonary infiltrates of cardiac origin
Show all 10Show fewer
- decreased GCS level
- PaCO2 > 10
- attending intensivist considering the patient unsuited for the prone position
- BMI > 33
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital Solna
Stockholm, 17176
Joha Petersson, MD, +46851772066, johan.petersson@karolinska.se
About this study
The study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure.
- Conditions
- Respiratory Failure
- Being tested
- Prone position
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Prone position during spontaneous breathing.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Prone position + all conventional treatment. Receives: Other: Prone position |
| Control | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for intubation and mechanical ventilation
Measured: Duration of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Karolinska 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Petersson, Karolinska University Hospital
- Investigators
- Johan Petersson, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526981
- Sponsor's protocol ID
- 2007/733-31/1-4
- Status last verified
- Sep 2011
- First submitted
- 6 Sep 2007
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position for Non-intubated Patients With Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00526981
- Acronym / sponsor ID
- 2007/733-31/1-4
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (estimated)
- First posted
- 10 Sep 2007 (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 study will test the hypothesis that the prone position can be used to reduce the need for intubation and mechanical ventilation in patients with acute respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Prone positionProne position + all conventional treatment. |
| Control | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bilateral pulmonary infiltrates or unilateral infiltrates involving more than one lobe on CXR
- PaO2/FIO2 < 40 kPa
- RR > 25, or attending intensivist considering likelihood of intubation > 50%
Key exclusion criteria (10 listed)
- unsuited for the prone position
- fulfilled inclusion criteria for more than 5 days (120 h)
- immunosuppression
- chronic lung disease
- decision of withdrawal or limitation of therapy
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 |
|---|---|---|
| Prone positionProne position during spontaneous breathing. | Other | Treatment |
Primary outcome
Need for intubation and mechanical ventilation
Time frame: Duration of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
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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.
Johan Petersson, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position in people with Respiratory Failure, run by Karolinska University Hospital 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Sep 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan Petersson, MD (+4685172066, johan.petersson@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for intubation and mechanical ventilation (time frame: Duration of hospital stay). 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 20 Sep 2011.