Acute Respiratory Distress SyndromeHIGHERNCT02214576
High Flow Nasal Canula Oxygen Helps Preoxygenate ARDS Patients
An observational study of Acute Respiratory Distress Syndrome, run by Hôpital Louis Mourier at 1 site in France.
Trial summary
Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Aug 2015
- 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: acute respiratory distress syndrome patients that require tracheal intubation in the ICU
Who may be able to join
- ARDS according to the Berlin criteria
- use of high flow nasal canula oxygen
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation
Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does not allow for apneic oxygenation and may not be performed in patients with neurological impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to determine its use as a means to ensure preoxygenation in those ARDS patients that require intubation.
Read the detailed description
High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in patients with acute respiratory failure. One of the major advantages of high flow nasal canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby providing high flow apneic oxygenation. In addition, and contrary no non-invasive ventilation, preoxygenation may be used in patients with neurological impairment. Finally, the interest of this device is that it is the same that is maintained throughout the whole management of the patient, from ICU admission to intubation.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome, Adult, intubation, intratracheal, Oxygen Inhalation Therapy, Positive-Pressure Respiration, laryngoscopy
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation
Measured: 30 minutes
Secondary outcomes (1)
complications
arrhythmia, hypotension, profound desaturation, cardiac arrest
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startSep 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Louis Mourier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Jean-Damien RICARD, Hôpital Louis Mourier
- Investigators
- Jean-Damien RICARD, MD, PhD, Principal investigator, University Paris Diderot and Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214576
- Sponsor's protocol ID
- HLM_JDR2
- Acronym
- HIGHER
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
PubMed 22531566Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
PubMed 21946925Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
PubMed 21958974Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
PubMed 25371400
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of High Flow Nasal Canula Oxygen to Preoxygenate ARDS Patients That Require Intubation
- ClinicalTrials.gov ID
- NCT02214576
- Acronym / sponsor ID
- HIGHER / HLM_JDR2
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Respiratory Distress Syndrome, Adult, intubation, intratracheal, Oxygen Inhalation Therapy, Positive-Pressure Respiration, laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hôpital Louis MourierUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Aug 2014 (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.
Tracheal intubation in the ICU is associated with significant complications and morbidity. Desaturation is among the most frequent and hazardous complication, occurring in almost one out of four intubations, that may in some instances lead to cardiac arrest; despite appropriate preoxygenation. Non-invasive ventilation may help improve preoxygenation but does not allow for apneic oxygenation and may not be performed in patients with neurological impairment. High flow nasal canula oxygen is increasingly used in the ICU in patients with acute hypoxemic respiratory failure and may be used to improve preoxygenation. It is currently used in our ICU for that purpose. Because high flow nasal canula oxygen is our first line oxyten therapy for patients with acute respirtory distress syndrome, we sought to determine its use as a means to ensure preoxygenation in those ARDS patients that require intubation.
Detailed description
High flow nasal canula oxygen is increasingly used to provide heated and humidified oxygen in patients with acute respiratory failure. One of the major advantages of high flow nasal canula oxygen is the possibility to maintain oxygenation during laryngoscopy and thereby providing high flow apneic oxygenation. In addition, and contrary no non-invasive ventilation, preoxygenation may be used in patients with neurological impairment. Finally, the interest of this device is that it is the same that is maintained throughout the whole management of the patient, from ICU admission to intubation.
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
- acute respiratory distress syndrome patients that require tracheal intubation in the ICU
Key inclusion criteria (2 listed)
- ARDS according to the Berlin criteria
- use of high flow nasal canula oxygen
Key exclusion criteria (1 listed)
- -
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
Oxygen saturation
Time frame: 30 minutes
oxygen saturation measured by pulse oxymetry during intubation and compared to levels before intubation
1 secondary outcome
complications
Time frame: 60 minutes
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 14 Aug 2015.
- Background: PubMed 22531566Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
- Background: PubMed 21946925Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
- Background: PubMed 21958974Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
- Background: PubMed 25371400Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.
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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.
Jean-Damien RICARD, MD, PhD principal investigator
University Paris Diderot and Assistance Publique - Hôpitaux de Paris
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 Acute Respiratory Distress Syndrome, run by Hôpital Louis Mourier 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 2 inclusion and 1 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 14 Aug 2015. 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?
Oxygen saturation (time frame: 30 minutes). 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 NCT02214576, which also lists 4 linked publications.
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 14 Aug 2015; AzTrials last refreshed its copy on 6 Nov 2026.