Extubation FailureNCT03361683
Post-extubation High-flow Nasal Oxygen for Preventing Extubation Failure
A study testing High-flow nasal oxygen and Venturi mask in people with Extubation Failure, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Patients intubated due to acute respiratory failure have a high risk of infectious complications, airway injuries and multiple organic failure, so performing a successful extubation from mechanical ventilation is key. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure
- What is being tested?
- High-flow nasal oxygen and Venturi mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteMexico
- Study dates
- 1 Oct 2017to 30 Jul 2019
- 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
- Hypoxemic primary acute respiratory failure
- Invasive mechanical ventilation for at least 48 hours
- Successful Spontaneous Breathing Trial
Who cannot join
- Immediate indication for invasive mechanical ventilation
- Immediate indication for non-invasive mechanical ventilation
- Self-extubation
- One or more failed Spontaneous Breathing Trial
- Chronic respiratory failure
- Neuromuscular diseases
Show all 10Show fewer
- Tracheostomy.
- Nasal cavity pathology
- Facial surgery
- Failure to authorize the informed consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Medical Science and Nutrition Salvador Zubirán,
México, 14080
About this study
Official title: Post-extubation High-flow Nasal Oxygen vs. Conventional Oxygen in Patients Recovered From Acute Hypoxemic Respiratory Failure for Preventing Extubation Failure
Patients intubated due to acute respiratory failure have a high risk of infectious complications, airway injuries and multiple organic failure, so performing a successful extubation from mechanical ventilation is key. Between 10 and 20% of patients develop extubation failure, which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. High-flow nasal oxygen therapy delivers heated, humidified air at flows up to 60L/min, and an oxygen concentration close to 100%, providing a fresh air reservoir at the naseo-pharyngeal level, evening out the peak inspiratory flow rate of the patient, improving air conductance, promoting secretion management, increasing end-expiratory lung volume, and applying a positive end-expiratory pressure. Such effects result in decreased breathing work, dyspnea relief, improved use tolerance, increased oxygenation, and lower fraction of inspired oxygen in patients with hypoxemic respiratory failure. High-flow oxygen therapy has recently been described to decrease extubation failure in a group of patients classified with low failure risk, in comparison to Venturi mask, and it was not inferior to non-invasive mechanical ventilation in high risk patients. However, it is worth pointing out that a large percentage of the patients included in such studies did not develop acute respiratory failure primarily.
Given the beneficial effects described above, the investigators hypothesize that high-flow nasal oxygen therapy decreases the risk of extubation failure in a group of patients that required invasive mechanical ventilation due to primary acute hypoxemic respiratory failure.
Read the detailed description
Intubated patients recovering from primary acute hypoxemic respiratory failure who have passed a spontaneous breathing trial will be included in the study. Following extubation, patients will be randomized assigned to one of two study groups. Heart rate, breathing rate, median arterial pressure, FiO2, SpO2, and dyspnea and comfort levels will be measured at defined intervals after extubation (basal, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours). An arterial blood gas test will be performed 60 minutes and 24 hours after extubation. The number of patients fulfilling certain preset criteria regarding extubation failure will be determined.
Extubation failure shall be defined as the need for using invasive mechanical ventilation again within two days following extubation based on the criteria below:
- Breathing rate over 25 breaths per minute for more than two hours.
- Heart rate above 140 beats per minute or with a sustained increase or decrease greater than 20%.
- Clinical data showing fatigue of the respiratory muscles or an increase in breathing work.
- SaO2 <90%; PaO2 <80 mmHg with a FiO2 > 50%.
- Hypercapnia (PaCO2 >45 mmHg or >20% compared to the value before extubation) with a pH below 7.33.
Patients who do not fulfill the extubation failure criteria after the first 48 hours of admission may receive extra supplementary oxygen through any device (e.g., nasal cannula, face mask, reservoir mask, etc.). Every day, SpO2 will be measured and the moment when the patient reaches SpO2 >94% with no need for oxygen will be determined.
- Conditions
- Extubation Failure
- Being tested
- High-flow nasal oxygen, Venturi mask
- Keywords
- High-Flow nasal oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal oxygenDevice
Randomized patients will receive oxygen through a high nasal flow device capable of delivering humidified, heated air at an output rate of 40 L/min
Venturi maskDevice
Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal oxygen | Experimental | Randomized patients will receive oxygen through a high flow nasal device capable of delivering humidified, heated air at an output rate of 40 L/min Receives: Device: High-flow nasal oxygen |
| Conventional oxygen | Active comparator | Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min Receives: Device: Venturi mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-extubation failure
Number of patients with extubation failure criteria in each group
Measured: First 48 hours
Secondary outcomes (12)
PaO2/FiO2 Ratio Record.
An arterial blood gas test will be performed once the high-flow oxygen or Venturi mask is placed.
Measured: Post-extubation period and up to 48 hours later.
Determination of FiO2 Requirements.
Assessment of FiO2 requirements at the time of extubation (when high-flow oxygen or Venturi mask is placed) and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours. The aim is to maintain SpO2 levels > 94% with the minimal FiO2 possible.
Measured: Post-extubation period and up to 48 hours later.
Respiratory Rate Record at Defined Intervals.
Quantification of respiratory rate at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.
Measured: Post-extubation period and up to 48 hours later.
Heart Rate Record at Defined Intervals.
Quantification of heart rate at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.
Measured: Post-extubation period and up to 48 hours later.
Mean Arterial Pressure Record at Defined Intervals.
Quantification of mean arterial pressure at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.
Measured: Post-extubation period and up to 48 hours later.
Treatment Comfort Assessment by means of a Visual Analogue Scale at Defined Intervals.
To record patient comfort by means of a Visual Analogue Scale tool at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.
Visual Analogue Scale range (0 = better to 10 = worse).
Measured: Post-extubation period and up to 48 hours later.
Dyspnea Assessment by means of a Visual Analog Scale at Defined Intervals.
To measure the level of dyspnea by means of a Visual Analogue Scale tool at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.
Visual Analogue Scale range (0 = better to 10 = worse).
Measured: Post-extubation period and up to 48 hours later.
Number of Days Requiring Oxygen after Successful Extubation
After successful extubation, the level of SpO2 will be measured on a daily basis, recording the time when a level of SpO2> 94% is reached by the patient without the use of supplemental oxygen.
Measured: Post-extubation period and up to 14 days later.
Number of Days Spent in the ICU after Extubation.
There will be quantified the total length of stay in the ICU after extubation.
Measured: Post-extubation period and up to 28 days later.
Days Spent in the Hospital After Extubation.
There will be quantified the total length of stay in the hospital after extubation.
Measured: Post-extubation period and up to 28 days later
Number of Deaths in the ICU after Extubation.
There will be quantified the number of patients deceased in each group
Measured: Post-extubation period and up to 28 days later
Number of Deaths in the Hospital after Extubation.
There will be quantified the number of patients deceased in each group
Measured: Post extubation period and up to 28 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Oct 2017
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Extubation 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose de Jesus Rodriguez-Andoney, MD, Principal investigator, National Institute of Medical Science and Nutrition Salvador Zubirán
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361683
- Sponsor's protocol ID
- REF-1350
- Status last verified
- Jul 2019
- First submitted
- 8 Nov 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.
PubMed 19294365Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
PubMed 19467849Dewan NA, Bell CW. Effect of low flow and high flow oxygen delivery on exercise tolerance and sensation of dyspnea. A study comparing the transtracheal catheter and nasal prongs. Chest. 1994 Apr;105(4):1061-5. doi: 10.1378/chest.105.4.1061.
PubMed 8162725Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
PubMed 22531566Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10.
PubMed 17931878Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
PubMed 21908497Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.
PubMed 17762844Chidekel A, Zhu Y, Wang J, Mosko JJ, Rodriguez E, Shaffer TH. The effects of gas humidification with high-flow nasal cannula on cultured human airway epithelial cells. Pulm Med. 2012;2012:380686. doi: 10.1155/2012/380686. Epub 2012 Sep 3.
PubMed 22988501Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.
PubMed 11331690Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
PubMed 20406507Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
PubMed 25003980Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.
PubMed 22417844Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
PubMed 26975498Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-extubation High-flow Nasal Oxygen vs. Conventional Oxygen in Patients Recovered From Acute Hypoxemic Respiratory Failure for Preventing Extubation Failure
- ClinicalTrials.gov ID
- NCT03361683
- Acronym / sponsor ID
- REF-1350
- Conditions
- Extubation Failure
- Keywords
- High-Flow nasal oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
Patients intubated due to acute respiratory failure have a high risk of infectious complications, airway injuries and multiple organic failure, so performing a successful extubation from mechanical ventilation is key. Between 10 and 20% of patients develop extubation failure, which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. High-flow nasal oxygen therapy delivers heated, humidified air at flows up to 60L/min, and an oxygen concentration close to 100%, providing a fresh air reservoir at the naseo-pharyngeal level, evening out the peak inspiratory flow rate of the patient, improving air conductance, promoting secretion management, increasing end-expiratory lung volume, and applying a positive end-expiratory pressure. Such effects result in decreased breathing work, dyspnea relief, improved use tolerance, increased oxygenation, and lower fraction of inspired oxygen in patients with hypoxemic respiratory failure. High-flow oxygen therapy has recently been described to decrease extubation failure in a group of patients classified with low failure risk, in comparison to Venturi mask, and it was not inferior to non-invasive mechanical ventilation in high risk patients. However, it is worth pointing out that a large percentage of the patients included in such studies did not develop acute respiratory failure primarily.
Given the beneficial effects described above, the investigators hypothesize that high-flow nasal oxygen therapy decreases the risk of extubation failure in a group of patients that required invasive mechanical ventilation due to primary acute hypoxemic respiratory failure.
Detailed description
Intubated patients recovering from primary acute hypoxemic respiratory failure who have passed a spontaneous breathing trial will be included in the study. Following extubation, patients will be randomized assigned to one of two study groups. Heart rate, breathing rate, median arterial pressure, FiO2, SpO2, and dyspnea and comfort levels will be measured at defined intervals after extubation (basal, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours). An arterial blood gas test will be performed 60 minutes and 24 hours after extubation. The number of patients fulfilling certain preset criteria regarding extubation failure will be determined.
Extubation failure shall be defined as the need for using invasive mechanical ventilation again within two days following extubation based on the criteria below:
- Breathing rate over 25 breaths per minute for more than two hours.
- Heart rate above 140 beats per minute or with a sustained increase or decrease greater than 20%.
- Clinical data showing fatigue of the respiratory muscles or an increase in breathing work.
- SaO2 <90%; PaO2 <80 mmHg with a FiO2 > 50%.
- Hypercapnia (PaCO2 >45 mmHg or >20% compared to the value before extubation) with a pH below 7.33.
Patients who do not fulfill the extubation failure criteria after the first 48 hours of admission may receive extra supplementary oxygen through any device (e.g., nasal cannula, face mask, reservoir mask, etc.). Every day, SpO2 will be measured and the moment when the patient reaches SpO2 >94% with no need for oxygen will be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal oxygen | Experimental | Device: High-flow nasal oxygenRandomized patients will receive oxygen through a high flow nasal device capable of delivering humidified, heated air at an output rate of 40 L/min |
| Conventional oxygen | Active comparator | Device: Venturi maskRandomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypoxemic primary acute respiratory failure
- Invasive mechanical ventilation for at least 48 hours
- Successful Spontaneous Breathing Trial
Key exclusion criteria (10 listed)
- Immediate indication for invasive mechanical ventilation
- Immediate indication for non-invasive mechanical ventilation
- Self-extubation
- One or more failed Spontaneous Breathing Trial
- Chronic respiratory failure
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 |
|---|---|---|
| High-flow nasal oxygenRandomized patients will receive oxygen through a high nasal flow device capable of delivering humidified, heated air at an output rate of 40 L/min | Device | High-flow nasal oxygen |
| Venturi maskRandomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min | Device | Conventional oxygen |
Primary outcome
Post-extubation failure
Time frame: First 48 hours
Number of patients with extubation failure criteria in each group
12 secondary outcomes
PaO2/FiO2 Ratio Record.
Time frame: Post-extubation period and up to 48 hours later.
Determination of FiO2 Requirements.
Time frame: Post-extubation period and up to 48 hours later.
Respiratory Rate Record at Defined Intervals.
Time frame: Post-extubation period and up to 48 hours later.
Heart Rate Record at Defined Intervals.
Time frame: Post-extubation period and up to 48 hours later.
Mean Arterial Pressure Record at Defined Intervals.
Time frame: Post-extubation period and up to 48 hours later.
Treatment Comfort Assessment by means of a Visual Analogue Scale at Defined Intervals.
Time frame: Post-extubation period and up to 48 hours later.
Dyspnea Assessment by means of a Visual Analog Scale at Defined Intervals.
Time frame: Post-extubation period and up to 48 hours later.
Number of Days Requiring Oxygen after Successful Extubation
Time frame: Post-extubation period and up to 14 days later.
Number of Days Spent in the ICU after Extubation.
Time frame: Post-extubation period and up to 28 days later.
Days Spent in the Hospital After Extubation.
Time frame: Post-extubation period and up to 28 days later
Number of Deaths in the ICU after Extubation.
Time frame: Post-extubation period and up to 28 days later
Number of Deaths in the Hospital after Extubation.
Time frame: Post extubation period and up to 28 days later.
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 8 Aug 2019.
- Results publication: PubMed 19294365Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.
- Results publication: PubMed 19467849Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
- Results publication: PubMed 8162725Dewan NA, Bell CW. Effect of low flow and high flow oxygen delivery on exercise tolerance and sensation of dyspnea. A study comparing the transtracheal catheter and nasal prongs. Chest. 1994 Apr;105(4):1061-5. doi: 10.1378/chest.105.4.1061.
- Results publication: PubMed 22531566Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
- Results publication: PubMed 17931878Groves N, Tobin A. High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care. 2007 Nov;20(4):126-31. doi: 10.1016/j.aucc.2007.08.001. Epub 2007 Oct 10.
- Results publication: PubMed 21908497Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
- Results publication: PubMed 17762844Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.
- Results publication: PubMed 22988501Chidekel A, Zhu Y, Wang J, Mosko JJ, Rodriguez E, Shaffer TH. The effects of gas humidification with high-flow nasal cannula on cultured human airway epithelial cells. Pulm Med. 2012;2012:380686. doi: 10.1155/2012/380686. Epub 2012 Sep 3.
- Results publication: PubMed 11331690Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. doi: 10.1542/peds.107.5.1081.
- Results publication: PubMed 20406507Roca O, Riera J, Torres F, Masclans JR. High-flow oxygen therapy in acute respiratory failure. Respir Care. 2010 Apr;55(4):408-13.
- Results publication: PubMed 25003980Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
- Results publication: PubMed 22417844Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.
- Individual participant dataSharing planned: No
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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.
Jose de Jesus Rodriguez-Andoney, MD principal investigator
National Institute of Medical Science and Nutrition Salvador Zubirán
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal oxygen and Venturi mask in people with Extubation Failure, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 10 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 8 Aug 2019. 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 Mexico. 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?
Post-extubation failure (time frame: First 48 hours). 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 NCT03361683, which also lists 14 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 8 Aug 2019.