Respiratory PhysiotherapyKISEVENNCT03114787
Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service?
A study testing Study on patients with respiratory resuscitation in people with Respiratory Physiotherapy and Resuscitation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Physiotherapy, Resuscitation
- What is being tested?
- Study on patients with respiratory resuscitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2016to 27 Apr 2017
- 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
- Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
- Major Patient over 18 years of age
- Patient affiliated to social security
Who cannot join
- Sedate
- With restrictive or tracheotomized syndrome
- With rib fractures
- Not able to benefit from physiotherapy within 3 hours after the start of the weaning protocol
- Refusal of patient or family
- Physiotherapy contraindications
- Patient under tutorship or curatorship
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial
Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation
- Conditions
- Respiratory Physiotherapy, Resuscitation
- Being tested
- Study on patients with respiratory resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study on patients with respiratory resuscitationOther
Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving respiratory physiotherapy | Other | Not described Receives: Other: Study on patients with respiratory resuscitation |
| Patient not receiving respiratory physiotherapy | Other | Not described Receives: Other: Study on patients with respiratory resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between initiation of weaning protocol and extubation.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start30 Aug 2016
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Why it stopped: The patient recruiting was stopped after 17 inclusions because of a reorganization of Intensive Care Units at the recruiting center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory PhysiotherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114787
- Sponsor's protocol ID
- PI2015_843_0014
- Acronym
- KISEVEN
- Status last verified
- Oct 2018
- First submitted
- 5 Apr 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03114787
- Acronym / sponsor ID
- KISEVEN / PI2015_843_0014
- Conditions
- Respiratory Physiotherapy, Resuscitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patient recruiting was stopped after 17 inclusions because of a reorganization of Intensive Care Units at the recruiting center.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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.
Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient receiving respiratory physiotherapy | Other | Other: Study on patients with respiratory resuscitation |
| Patient not receiving respiratory physiotherapy | Other | Other: Study on patients with respiratory resuscitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
- Major Patient over 18 years of age
- Patient affiliated to social security
Key exclusion criteria (8 listed)
- Sedate
- With restrictive or tracheotomized syndrome
- With rib fractures
- Not able to benefit from physiotherapy within 3 hours after the start of the weaning protocol
- Refusal of patient or family
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 |
|---|---|---|
| Study on patients with respiratory resuscitationPatient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult | Other | Patient not receiving respiratory physiotherapy, Patient receiving respiratory physiotherapy |
Primary outcome
Time between initiation of weaning protocol and extubation.
Time frame: 8 months
Results and safety
The study was stopped early (reason given: The patient recruiting was stopped after 17 inclusions because of a reorganization of Intensive Care Units at the recruiting center.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
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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 Study on patients with respiratory resuscitation in people with Respiratory Physiotherapy and Resuscitation, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 8 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: stopped early, as of the sponsor's last update on 4 Oct 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 France. 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 stopped early (reason given: The patient recruiting was stopped after 17 inclusions because of a reorganization of Intensive Care Units at the recruiting center.). Results are not available in the source record.
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?
Time between initiation of weaning protocol and extubation. (time frame: 8 months). 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 4 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.