Respiratory FailureNCT00190346
Comparison of Humidification Devices During Non Invasive Ventilation, in Acute Respiratory Failure
A study testing Humidification devices: HH vs HME in people with Respiratory Failure and COPD, run by Assistance Publique - Hôpitaux de Paris at 14 sites in 4 countries.
Trial summary
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure. The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Failure, COPD, Hypoxemia
- What is being tested?
- Humidification devices: HH vs HME
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Dec 2001to Apr 2003
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years
- Exacerbation of dyspnea lasting less than two weeks
- TWO OR THREE following criteria :
- Respiratory rate higher or equal to 25 b/min
- SaO2 lower or equal to 90% (breathing room air or oxygen)
- Arterial pH < 7.35
Who cannot join
- immediate need for intubation
- cardiac arrest or RR< 10 breaths/min.
- systemic hypotension (SAP < 80 mmHg ) with no response to 500 ml of macromolecules
- coma defined by GCS < 8.
- high probability of surgical procedure
- major facial deformity
Show all 9Show fewer
- pneumothorax
- bad short-term prognosis
- refusal of intubation by the patient or do not intubated order.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
France11 sites
Hôpital Victor Dupouy, Argenteuil
Argenteuil
CHU de La Cavale Blanche
Brest
Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon
Clichy
Réanimation Médicale - Hôpital Louis Mourier
Colombes
Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi
Montpellier
Hôpital Georges Pompidou HEGP
Paris
Réanimation du Service Pneumologie - Hôtel Dieu
Paris
Réanimation pneumologique, Hôpital Pitié Salpétrière
Paris
Réanimation Pneumologique- CHU Tenon
Paris
Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy
Poissy
Réanimation Médicale, Hôpital Charles Nicolle
Rouen
Canada1 site
Département d'Anesthésie - Hôpital de l'Enfant Jésus
Québec, Quebec
Italy1 site
Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli
Roma
About this study
Official title: Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.
The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.
Read the detailed description
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.
The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comlparison with HH Several physiological previously performed showed that 1) with HME, because of its working principles, humidification was reduced because of leaks 2) work of breathing was increased with HME because of dead space and 3) alveolar ventilation was reduced with HME because of additional technical dead space.
For these reasons, the hypothesis was an improvement of NIV tolerance, of efficiency to clear te CO2 with HH in comparison with HME and finally to reduce the intubation rate with HH.
The patients were included when requiring NIV (see inclusion and exclusion criteria) and randomisation was performed with stratification according to presence or absence of respiratory acidosis.
The number of patients to include was baszd on the hypothesis that intubation rate would be reduced from 40 with HME to 25% with HME. A total of 250 patients was required with alpha risk of 0,05 and beta risk of 0,2 (power 80%). Intubation criteria were predefined according to the litterature. The expected duration was 18 months. The official support was institutional (DRRC of AP-HP). HH were furnished free of charge, as well as HME. Masks used were the same in both groups.
- Conditions
- Respiratory Failure, COPD, Hypoxemia, Non Invasive Ventilation
- Being tested
- Humidification devices: HH vs HME
- Keywords
- Acute respiratory distress, with hypercapnia, with hypoxemia, requiring NIV
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Hypoxia, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidification devices: HH vs HMEDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Measured: during the study
Secondary outcomes (7)
-Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)
Measured: during the study
-Intolerance of NIV
Measured: during the study
- Frequency of VAP
Measured: during the study
- Duration of total MV duration
Measured: during the study
- ICU LOS
Measured: during the study
- Hospital LOS
Measured: during the study
- Mortality (ICU and hospital)
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2001
- Study completionApr 2003
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Best, Study chair, DRRC hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190346
- Sponsor's protocol ID
- PHRC 2001
- Status last verified
- Aug 2005
- First submitted
- 13 Sep 2005
- Last updated
- 26 Oct 2011
- Results posted
- No
Publications
Lellouche F, L'Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, Jaber S, Fartoukh M, Conti G, Cracco C, Richard JC, Ricard JD, Mal H, Mentec H, Loisel F, Lacherade JC, Taille S, Brochard L. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):211-219. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.
PubMed 24275900
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT00190346
- Acronym / sponsor ID
- PHRC 2001
- Conditions
- Respiratory Failure, COPD, Hypoxemia, Non Invasive Ventilation
- Keywords
- Acute respiratory distress, with hypercapnia, with hypoxemia, requiring NIV
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 250 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Apr 2003
- First posted
- 19 Sep 2005 (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.
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.
The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.
Detailed description
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.
The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comlparison with HH Several physiological previously performed showed that 1) with HME, because of its working principles, humidification was reduced because of leaks 2) work of breathing was increased with HME because of dead space and 3) alveolar ventilation was reduced with HME because of additional technical dead space.
For these reasons, the hypothesis was an improvement of NIV tolerance, of efficiency to clear te CO2 with HH in comparison with HME and finally to reduce the intubation rate with HH.
The patients were included when requiring NIV (see inclusion and exclusion criteria) and randomisation was performed with stratification according to presence or absence of respiratory acidosis.
The number of patients to include was baszd on the hypothesis that intubation rate would be reduced from 40 with HME to 25% with HME. A total of 250 patients was required with alpha risk of 0,05 and beta risk of 0,2 (power 80%). Intubation criteria were predefined according to the litterature. The expected duration was 18 months. The official support was institutional (DRRC of AP-HP). HH were furnished free of charge, as well as HME. Masks used were the same in both groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 85 years
- Exacerbation of dyspnea lasting less than two weeks
- Respiratory rate higher or equal to 25 b/min
- SaO2 lower or equal to 90% (breathing room air or oxygen)
- Arterial pH < 7.35
Key exclusion criteria (9 listed)
- immediate need for intubation
- cardiac arrest or RR< 10 breaths/min.
- systemic hypotension (SAP < 80 mmHg ) with no response to 500 ml of macromolecules
- coma defined by GCS < 8.
- high probability of surgical procedure
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 |
|---|---|---|
| Humidification devices: HH vs HME | Device | – |
Primary outcome
Intubation rate
Time frame: during the study
7 secondary outcomes
-Physiological outcome at 1,3 and 6 hours (arterial blood gases, respiratory rate)
Time frame: during the study
-Intolerance of NIV
Time frame: during the study
- Frequency of VAP
Time frame: during the study
- Duration of total MV duration
Time frame: during the study
- ICU LOS
Time frame: during the study
- Hospital LOS
Time frame: during the study
- Mortality (ICU and hospital)
Time frame: during the study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
- Derived from this study: PubMed 24275900Lellouche F, L'Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, Jaber S, Fartoukh M, Conti G, Cracco C, Richard JC, Ricard JD, Mal H, Mentec H, Loisel F, Lacherade JC, Taille S, Brochard L. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):211-219. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.
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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.
Nicolas Best study chair
DRRC hopitaux de Paris
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidification devices: HH vs HME in people with Respiratory Failure and COPD, run by Assistance Publique - Hôpitaux de Paris at 14 sites in 4 countries.
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 6 inclusion and 9 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 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Canada, Italy, Tunisia. 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. 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?
Intubation rate (time frame: during the study). 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 NCT00190346, 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 26 Oct 2011.