Weaning From Mechanical VentilationNCT01967108
Post Extubation Chest Physiotherapy in ICU
A study testing chest physiotherapy in people with Weaning From Mechanical Ventilation, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning From Mechanical Ventilation
- What is being tested?
- chest physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Mar 2015
- 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
Inclusion Criteria:ICU patients, over 18 years' old, mechanical ventilated over 24 hours, candidates for extubation -
Exclusion Criteria: Mental conditions, retardation, dementia, pregnancy, re-intubated patients
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Post Extubation Chest Physiotherapy on Respiratory Complications and Weaning Failure in Critically Ill Patients
The purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.
- Conditions
- Weaning From Mechanical Ventilation
- Being tested
- chest physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest physiotherapyOther
chest physiotherapy, up to one hour from extubation, in ICU patients
| Study group | Role | What they receive |
|---|---|---|
| chest physiotherapy | Experimental | chest physiotherapy in patient's bed, including deep breathing, directed cough, arm movment and more. Receives: Other: chest physiotherapy |
| control group | No intervention | This patients will not recive chest physiotherapy after extubation, unless developing respiratory deterioration |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-intubation
re-intubation up to 48 hours post extubation will be considered a weaning failure
Measured: 48 hours
Secondary outcomes (1)
oxygen saturation decrease
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning From Mechanical VentilationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enbar Foox, B.PT, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967108
- Sponsor's protocol ID
- 0346-13-RMB CTIL
- Status last verified
- Feb 2014
- First submitted
- 17 Oct 2013
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post Extubation Chest Physiotherapy on Respiratory Complications and Weaning Failure in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01967108
- Acronym / sponsor ID
- 0346-13-RMB CTIL
- Conditions
- Weaning From Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Oct 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 examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chest physiotherapy | Experimental | Other: chest physiotherapychest physiotherapy in patient's bed, including deep breathing, directed cough, arm movment and more. |
| control group | No intervention | –This patients will not recive chest physiotherapy after extubation, unless developing respiratory deterioration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| chest physiotherapychest physiotherapy, up to one hour from extubation, in ICU patients | Other | chest physiotherapy |
Primary outcome
re-intubation
Time frame: 48 hours
re-intubation up to 48 hours post extubation will be considered a weaning failure
1 secondary outcome
oxygen saturation decrease
Time frame: 48 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 7 May 2015.
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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.
Enbar Foox, B.PT principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chest physiotherapy in people with Weaning From Mechanical Ventilation, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 May 2015. 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 Israel. 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?
re-intubation (time frame: 48 hours). 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 7 May 2015.