Adult Patients Ventilated More Than 48 hHiFloLUSNCT01702779
Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study
A study testing mechanical ventilation in people with Adult Patients Ventilated More Than 48 h and Stable Respiratory and Hemodynamic Conditions for SBT, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients
- What is being tested?
- mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Jun 2013
- 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
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Who cannot join
- COBP
- Laryngeal dyspnea
- Tracheostomy
- Arythmya
- No echogenicity
- Paraplegia >T8
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
Read the detailed description
Prospective randomized clinical multicentric study on ICU (Intensive Care University) comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound Score during weaning from mechanical ventilation
- Conditions
- Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients, Arterial Line
- Being tested
- mechanical ventilation
- Keywords
- Weaning from mechanical ventilation, Lung ultrasound, Oxygen inhalation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationOther
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
mechanical ventilationOther
Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| optiflow | Other | Not described Receives: Other: mechanical ventilation |
| O2 | Other | Not described Receives: Other: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
variations of lung ultrasound score
Measured: 24 hours after extubation
Secondary outcomes (4)
Lung ultrasound score
Measured: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
rates of patients with postextubation distress
Measured: during the 48th post-extubation
Electrical Impedance tomography
Measured: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
Epithelial and endothelial biomarkers
Measured: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Ventilated More Than 48 hStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
- Investigators
- Sébastien PERBET, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702779
- Sponsor's protocol ID
- CHU-0107
- Acronym
- HiFloLUS
- Status last verified
- Nov 2014
- First submitted
- 24 Apr 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Humidified High Flow Oxygen During Weaning From Mechanical Ventilation : Ultrasonography Study
- ClinicalTrials.gov ID
- NCT01702779
- Acronym / sponsor ID
- HiFloLUS / CHU-0107
- Conditions
- Adult Patients Ventilated More Than 48 h, Stable Respiratory and Hemodynamic Conditions for SBT, Consent of Patients, Arterial Line
- Keywords
- Weaning from mechanical ventilation, Lung ultrasound, Oxygen inhalation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Oct 2012 (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.
This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
Detailed description
Prospective randomized clinical multicentric study on ICU (Intensive Care University) comparing nasal humidified high flow therapy versus standard oxygen with Lung Ultrasound Score during weaning from mechanical ventilation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optiflow | Other | Other: mechanical ventilation |
| O2 | Other | Other: mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ventilated more than 48 h
- Stable respiratory and hemodynamic conditions for SBT
- Consent of patients
- Arterial line
Key exclusion criteria (6 listed)
- COBP
- Laryngeal dyspnea
- Tracheostomy
- Arythmya
- No echogenicity
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 |
|---|---|---|
| mechanical ventilationProspective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation. | Other | optiflow |
| mechanical ventilationProspective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation. | Other | O2 |
Primary outcome
variations of lung ultrasound score
Time frame: 24 hours after extubation
4 secondary outcomes
Lung ultrasound score
Time frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
rates of patients with postextubation distress
Time frame: during the 48th post-extubation
Electrical Impedance tomography
Time frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
Epithelial and endothelial biomarkers
Time frame: at baseline, 4-6 hours after extubation, 24 hours after extubation, 48 hours after extubation
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 2 Dec 2014.
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.
Sébastien PERBET principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical ventilation in people with Adult Patients Ventilated More Than 48 h and Stable Respiratory and Hemodynamic Conditions for SBT, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 6 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 2 Dec 2014. 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.
What does the primary outcome measure?
variations of lung ultrasound score (time frame: 24 hours after extubation). 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 2 Dec 2014.