Chronic Respiratory FailureROOMILANCT01255111
Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure (ROOMILA)
An observational study of Chronic Respiratory Failure, run by Groupe de Recherche sur le Handicap Respiratoire at 1 site in France.
Trial summary
BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure. AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jun 2011
- Phase
- Observational
- 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
Study population: Patients with chronic respiratory failure at stable state who are indicated to domiciliary noninvasive ventilation
Who may be able to join
- Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines.
Who cannot join
- Decompensated respiratory failure attested by a pH <7.35,
- Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection,
- Respiratory frequency >30/min.
Trial locations and contacts
1 site in 1 country.
France1 site
Pulmonary & Respiratory Intensive Care Department - Rouen University Hospital
Rouen
About this study
Official title: Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure
BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure.
AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory.
Read more
PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep.
EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.
- Conditions
- Chronic Respiratory Failure
- Keywords
- Chronic respiratory failure, Noninvasive ventilation, Patient-ventilator interactions, Sleep, Sleep fragmentation
- Medical subject headings
- Sleep Deprivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startOct 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe de Recherche sur le Handicap Respiratoire
- Sponsor type
- University, hospital or other
- Investigators
- Pr. Antoine CUVELIER, MD, PhD, Principal investigator, Groupe de Recherche sur le Handicap Ventilatoire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255111
- Sponsor's protocol ID
- 2010AC1
- Acronym
- ROOMILA
- Status last verified
- Jun 2011
- First submitted
- 4 Dec 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation to Nocturnal Noninvasive Ventilation in Patients With Chronic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01255111
- Acronym / sponsor ID
- ROOMILA / 2010AC1
- Conditions
- Chronic Respiratory Failure
- Keywords
- Chronic respiratory failure, Noninvasive ventilation, Patient-ventilator interactions, Sleep, Sleep fragmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Groupe de Recherche sur le Handicap RespiratoireUniversity, hospital or other
- Study start
- Oct 2010
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Dec 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.
BACKGROUND: Adaptation to noninvasive ventilation (NIV) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure.
AIM: To study the variability of patient-ventilator interactions during the first nights after initiation to NIV. Recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory.
PATIENTS AND METHODS: Patients with chronic respiratory failure at stable state and indicated to home NIV will be included. All patients will perform three polysomnographies (under spontaneous breathing at D1 and under NIV at D2 and D15 after NIV initiation). All ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under NIV in the Sleep Laboratory of the Department and secondarily related to sleep architecture and quality of sleep.
EXPECTED RESULTS: This study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal NIV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic respiratory failure at stable state who are indicated to domiciliary noninvasive ventilation
Key inclusion criteria (1 listed)
- Chronic respiratory failure with indication to domiciliary NIV according to the international guidelines.
Key exclusion criteria (3 listed)
- Decompensated respiratory failure attested by a pH <7.35,
- Modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection,
- Respiratory frequency >30/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Jun 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.
Pr. Antoine CUVELIER, MD, PhD principal investigator
Groupe de Recherche sur le Handicap Ventilatoire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure, run by Groupe de Recherche sur le Handicap Respiratoire 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 1 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 23 Jun 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 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 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.
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 23 Jun 2011.