Neurologic DisorderNCT01143103
Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder
A study testing Cough assist (Philips,respironics) and Usual respiratory therapy in people with Neurologic Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Cough assist (Philips,respironics) and Usual respiratory therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peak flow < 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia
Who cannot join
- Death expected in the following 24h
- Bulbar dysfunction if extubated
- pneumothorax
- intracerebral mass effect
- elevated intracranial pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder
The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.
- Conditions
- Neurologic Disorder
- Being tested
- Cough assist (Philips,respironics), Usual respiratory therapy
- Keywords
- Respiratory therapy in neurologic disorder
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cough assist (Philips,respironics)Device
Usual respiratory therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Respiratory therapy with cough assist | Experimental | Not described Receives: Device: Cough assist (Philips,respironics) |
| Usual respiratory therapy | Active comparator | Not described Receives: Other: Usual respiratory therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of stay in intensive care unit
Number of additional unplanned respiratory therapy treatment
Secondary outcomes (5)
Duration of stay in the hospital
Pulmonary infection
Oxygenation parameters before and after respiratory therapy
Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available
Need of reintubation in the 48h following successful intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Didier Tassaux, Study director, University Hospital, GenevaLise Piquilloud, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143103
- Sponsor's protocol ID
- cough assist
- Other IDs
- cough assist
- Status last verified
- Jun 2010
- First submitted
- 2 Jun 2010
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder
- ClinicalTrials.gov ID
- NCT01143103
- Acronym / sponsor ID
- cough assist
- Conditions
- Neurologic Disorder
- Keywords
- Respiratory therapy in neurologic disorder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 Jun 2010 (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 present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory therapy with cough assist | Experimental | Device: Cough assist (Philips,respironics) |
| Usual respiratory therapy | Active comparator | Other: Usual respiratory therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peak flow < 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia
Key exclusion criteria (5 listed)
- Death expected in the following 24h
- Bulbar dysfunction if extubated
- pneumothorax
- intracerebral mass effect
- elevated intracranial pressure
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 |
|---|---|---|
| Cough assist (Philips,respironics) | Device | Respiratory therapy with cough assist |
| Usual respiratory therapy | Other | Usual respiratory therapy |
Primary outcome
Duration of stay in intensive care unit
Number of additional unplanned respiratory therapy treatment
5 secondary outcomes
Duration of stay in the hospital
Pulmonary infection
Oxygenation parameters before and after respiratory therapy
Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available
Need of reintubation in the 48h following successful intubation
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 24 Sep 2012.
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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.
Didier Tassaux study director
University Hospital, Geneva
Lise Piquilloud principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cough assist (Philips,respironics) and Usual respiratory therapy in people with Neurologic Disorder, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 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 24 Sep 2012. 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 Switzerland. 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?
Duration of stay in intensive care unit. The study lists 2 primary outcomes in all. 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 24 Sep 2012.