Respiratory FailureVHYPERNCT01047852
Noninvasive Ventilation After Extubation in Hypercapnic Patients
A study testing Noninvasive ventilation in people with Respiratory Failure, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Noninvasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2010to Aug 2011
- 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
- Patients intubated for 48 hours or more
- Patients with Chronic respiratory disorders
- And/or hypercapnic respiratory failure during successful spontaneous breathing trial
Who cannot join
- Face or cranial trauma or surgery
- Home noninvasive ventilation
- Recent gastric or oesophageal surgery
- Tracheostomy or other upper airway disorders
- Upper gastrointestinal bleeding
- Excess respiratory secretions
- Lack of collaboration
- Do not resuscitate order or any decision to limit therapeutic effort in the ICU.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hospital
Agen, 47923
Saint-André Hospital
Bordeaux, 33075
Pellegrin Hospital, Recovery Unit
Bordeaux, 33076
Hospital
Libourne, 33505
University Hospital
Limoges, 87042
University Hospital
Toulouse, 31059
About this study
Official title: Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders
The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.
Read the detailed description
Reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. Patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. This is associated to increased incidence of extubation failure and mortality. Although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. NIV does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. However, a recent randomised study demonstrated that the early use of NIV averted respiratory failure after extubation in patients at increased risk. The patients were considered at risk if they had at least one of the following criteria: age > 65 years, cardiac failure, increased severity assessed by an Acute Physiologic and Chronic Health Evaluation score > 12. But, the beneficial effects of NIV on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. So the beneficial effects of NIV should be confirmed in a trial in this specific population. We planned to conduct a study evaluating the efficacy of NIV in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to NIV group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, ICU and hospital length of stay.
- Conditions
- Respiratory Failure
- Being tested
- Noninvasive ventilation
- Keywords
- chronic respiratory disorders, hypercapnic respiratory failure, noninvasive ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilationProcedure or surgery
NIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| NIV | Experimental | Not described Receives: Procedure: Noninvasive ventilation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory failure after extubation
Measured: 2 days
Secondary outcomes (6)
Incidence of reintubation
Measured: 2 months
Length of stay in Intensive Care Unit
Measured: 2 months
Hospital mortality
Measured: 2 months
Survival
Measured: 28th day
Survival
Measured: 90th day
Incidence of complications associated to mechanical ventilation
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VARGAS, MD, Principal investigator, University Hospital, Bordeaux, FranceOlivier GUISSET, MD, Principal investigator, University Hospital, Bordeaux, FranceMarc CLAVEL, MD, Principal investigator, University Hospital, Limoges, FrancePascale SANCHEZ, MD, Principal investigator, University Hospital, Toulouse, FranceSylvain GARNIER, MD, Principal investigator, Hospital, Libourne, FranceAissa KHERCHACHE, MD, Principal investigator, Hospital, Agen, FranceAntoine BENARD, MD, Study chair, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047852
- Sponsor's protocol ID
- CHUBX 2009/10
- Acronym
- VHYPER
- Status last verified
- Mar 2015
- First submitted
- 5 Jan 2010
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Vargas F, Clavel M, Sanchez-Verlan P, Garnier S, Boyer A, Bui HN, Clouzeau B, Sazio C, Kerchache A, Guisset O, Benard A, Asselineau J, Gauche B, Gruson D, Silva S, Vignon P, Hilbert G. Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER). Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.
PubMed 28393258
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders
- ClinicalTrials.gov ID
- NCT01047852
- Acronym / sponsor ID
- VHYPER / CHUBX 2009/10
- Conditions
- Respiratory Failure
- Keywords
- chronic respiratory disorders, hypercapnic respiratory failure, noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Jan 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 purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.
Detailed description
Reintubation, which occurs in 6 to 23% within 48 to 72 hours after planned extubation, is a relevant consequence of respiratory failure after extubation. Patients with chronic respiratory disorders and invasively mechanically ventilated in intensive care unit, often exhibit hypercapnia, during breathing trial prior extubation. This is associated to increased incidence of extubation failure and mortality. Although the need for reintubation may be a marker of increased severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. NIV does not seem to be beneficial in avoiding reintubation when these patients have developed respiratory failure. However, a recent randomised study demonstrated that the early use of NIV averted respiratory failure after extubation in patients at increased risk. The patients were considered at risk if they had at least one of the following criteria: age > 65 years, cardiac failure, increased severity assessed by an Acute Physiologic and Chronic Health Evaluation score > 12. But, the beneficial effects of NIV on survival appear to be restricted to patients with chronic respiratory disorders and hypercapnia during the spontaneous breathing trial. So the beneficial effects of NIV should be confirmed in a trial in this specific population. We planned to conduct a study evaluating the efficacy of NIV in the prevention of extubation failure and mortality in these patients. If no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to NIV group or control group. The clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the ICU and hospital mortality, 28-day survival, the complications associated to mechanical ventilation, ICU and hospital length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV | Experimental | Procedure: Noninvasive ventilation |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients intubated for 48 hours or more
- Patients with Chronic respiratory disorders
- And/or hypercapnic respiratory failure during successful spontaneous breathing trial
Key exclusion criteria (8 listed)
- Face or cranial trauma or surgery
- Home noninvasive ventilation
- Recent gastric or oesophageal surgery
- Tracheostomy or other upper airway disorders
- Upper gastrointestinal bleeding
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 |
|---|---|---|
| Noninvasive ventilationNIV will be delivered using a sequential mode (a minimum of 1 hour every 3 hours) immediately after extubation for a schedule period of 48 h after extubation. In between NIV courses ((NIV-free periods) O2 will be administered through nasal cannula in order to obtain a SaO2 ≥ 90%. Afterward, NIV will be withdraw and oxygen will be administered by nasal cannula | Procedure or surgery | NIV |
Primary outcome
Incidence of respiratory failure after extubation
Time frame: 2 days
6 secondary outcomes
Incidence of reintubation
Time frame: 2 months
Length of stay in Intensive Care Unit
Time frame: 2 months
Hospital mortality
Time frame: 2 months
Survival
Time frame: 28th day
Survival
Time frame: 90th day
Incidence of complications associated to mechanical ventilation
Time frame: 2 months
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 5 Mar 2015.
- Derived from this study: PubMed 28393258Vargas F, Clavel M, Sanchez-Verlan P, Garnier S, Boyer A, Bui HN, Clouzeau B, Sazio C, Kerchache A, Guisset O, Benard A, Asselineau J, Gauche B, Gruson D, Silva S, Vignon P, Hilbert G. Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER). Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.
Related trials for Respiratory Failure
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Recruiting
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
Chronic Respiratory Failure, Acute Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
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.
Frédéric VARGAS, MD principal investigator
University Hospital, Bordeaux, France
Olivier GUISSET, MD principal investigator
University Hospital, Bordeaux, France
Marc CLAVEL, MD principal investigator
University Hospital, Limoges, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation in people with Respiratory Failure, run by University Hospital, Bordeaux at 6 sites 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: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Incidence of respiratory failure after extubation (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047852, which also lists 1 linked publication.
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 5 Mar 2015.