HypoxemiaEPHYRENCT06688487
Postoperative Extubation in Hypoxemic Patients
A study testing early extubation of hypoxemic patients in people with Hypoxemia and Extubation, run by Fondation Hôpital Saint-Joseph at 12 sites in France.
Trial summary
The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Extubation, Postoperative Respiratory Complication
- What is being tested?
- early extubation of hypoxemic patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 12 sitesFrance
- Study dates
- 18 Nov 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Francophone patient affiliated to a health insurance plan;
- Patient having granted free, informed and written consent to participate in the study;
- Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L/min or FiO2 40% during spontaneous breathing trial.
Who cannot join
- Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);
- Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L/min or FiO2 = 50%;
- Presence of poor clinical tolerance of SBT defined by polypnoea above 30/min, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;
- Presence of an ineffective cough or major bronchial congestion;
- Patient already included in a type 1 interventional research protocol (RIPH1), modifying the procedure for ventilatory weaning and/or ventilatory support after extubation;
- Anatomical factors precluding the use of NIV or high-flow oxygen therapy, notably facial or cervico-facial malformations;
Show all 16Show fewer
- Tracheostomized patient;
- History of obstructive ventilatory disorders with indication for NIV post-extubation, chronic obstructive pulmonary disease (COPD) GOLD score III/IV;
- History of obstructive sleep apnea syndrome with equipment;
- cardiogenic pulmonary edema;
- Patient on extracorporeal membrane oxygenation (ECMO) at the time of inclusion;
- Patient under guardianship or curatorship;
- Minor patients;
- Patient deprived of liberty or under court protection;
- Pregnant or breast-feeding women;
- Patient in therapeutic limitation with decision not to re-intubate.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites
centre hospitalier Victor Dupouy
Argenteuil, 95107
Gaetan Plantefeve, MD, 0134231445, gaetan.plantefeve@ch-argenteuil.fr
Gaetan Plantefeve
CHRU de Besançon
Besançon, 25030
Sebastien Pili-Floury, MD, PhD, 03 81 66 81 66, spilifloury@chu-besancon.fr
Sebastien Pili-Floury
Marie Lannelongue Hospital
Le Plessis-Robinson, 92350
Thibaut Genty, MD, 0140942260, t.genty@ghpsj.fr
francois stéphan, MD, PhD, 0144128580, f.stephan@ghpsj.fr
Hôpital Saint Eloi, CHU Montpellier
Montpellier, 34090
Samir Jaber, MD, PhD, 04 67 33 72 71, s-jaber@chumontpellier.fr
Samir Jaber
CHU la pitié salpêtrière
Paris, 75013
Jean Michel Constantin, MD, PhD, 01.42.16.22.59, jean-michel.constantin@aphp.fr
Jean Michel Constantin
CHU la pitié salpêtrière
Paris, 75013
Adrien Bougle, MD, PhD, 01 42 16 29 91, adrien.bougle@aphp.fr
Adrien Bougle
CHU la pitié Salpêtrière
Paris, 75013
Antoine Monsel, MD, PhD, 01 42 17 58 89, antoine.monsel@aphp.fr
Antoine Monsel
Institut mutualiste Montsouris
Paris, 75014
Alexy Tran Dinh, MD, 01 56 61 61 88, Alexy.tran-dinh@imm.fr
Alexy Tran Dinh
réanimation polyvalente hopital saint joseph groupe hospitalier Paris saint Joseph
Paris, 75014
Cédric Bruel, MD, 0144127856, cbruel@ghpsj.fr
Cédric Bruel
hôpital george Pompidou
Paris, 75015
Bernard Cholley, MD, PhD, 0156092515, bernard.cholley@aphp.fr
Bernard Cholley
CHU de Reims
Reims, 51092
Salvatore Muccio, MD, 03 10 73 66 50, smuccio@chu-reims.fr
Salvatore Muccio
Centre Cardiologique Du Nord
Saint-Denis, 93200
Jean Michel Maillet, MD, 0149334141, jm.mailletmascarel@gmail.com
Jean Michel Maillet
About this study
Official title: Early Postoperative Extubation in Hypoxemic ICU Patients: a Multicenter, Randomized Controlled Trial
The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:
Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).
Read the detailed description
International guidelines recommend extubating patients after correction of hypoxemia, meaning if the SpO2 measured during the spontaneous breathing trial is above 92%. However, there is strong rationale for modifying this practice to extubate patients earlier, particularly those presenting with hypoxemia after major surgery, by using alternating non-invasive ventilation (NIV) and high-flow oxygen therapy:
Several studies have found no link between patient oxygenation and extubation success, where outcomes for hypoxemic and non-hypoxemic patients are similar. Isolated hypoxemia thus does not appear to be a predictor of reintubation.
Hypoxemia is very common following major surgery, primarily due to shunts caused by atelectasis. Treatment for these atelectasis includes airway pressurization, bronchial secretion drainage, mobilization, and reducing factors that lead to diaphragmatic dysfunction.
In patients on invasive mechanical ventilation, secretion drainage is impaired, and mobilization to a seated position is more challenging. It has also been shown that diaphragmatic dysfunction occurs with prolonged ventilation. Hypoxemia can therefore be sustained by invasive ventilation, increasing the risk of therapeutic escalation.
Current guidelines do not account for the widespread use of non-invasive assistance techniques (such as high-flow oxygen therapy and non-invasive ventilation) that are now routinely employed in intensive care. These techniques allow for adequate oxygenation with high patient comfort and good tolerance.
Prolonging invasive ventilation in hypoxemic patients, as recommended by guidelines, could lead to associated complications. In contrast, early extubation of patients with hypoxemia may reduce the duration of both invasive and non-invasive ventilation, as well as complications related to prolonged invasive ventilation, without increasing the risk of reintubation.
Compared to continuing mechanical ventilation until hypoxemia is corrected, extubating purely hypoxemic patients and transitioning them to non-invasive ventilation techniques could represent a significant improvement in patient care.
- Being tested
- early extubation of hypoxemic patients
- Keywords
- extubation, hypoxemia, postoperative respiratory complication, weaning, facilitative non invasive strategy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early extubation of hypoxemic patientsOther
patient extubated after the spontaneous ventilation trial despite the presence of hypoxemia defined by SpO2 ≤ 90% either in T-piece under 6 L/min, or under FiO2 = 40% if SBT is performed in spontaneous ventilation with minimal inspiratory assistance.
| Study group | Role | What they receive |
|---|---|---|
| hypoxemic extubation group | Experimental | Randomized patients exhibit relative hypoxemia, defined by an SpO2 ≤ 90% while receiving 6 liters of oxygen or FiO2 of 40%. They must not have severe hypoxemia, defined as an SpO2 < 86% while receiving 9 liters of oxygen or FiO2 of 50%. Additionally, they must not show clinical signs of poor tolerance to the spontaneous breathing trial. Patients randomized to the "hypoxemic extubation group" are extubated despite the presence of relative hypoxemia after one hour of reventilation. Following extubation, a non-invasive oxygenation strategy is initiated, alternating between non-invasive ventilation and high-flow oxygen therapy for a minimum of 24 hours. Receives: Other: early extubation of hypoxemic patients |
| conventional extubation group | No intervention | Patients in the conventional extubation group also present with relative hypoxemia, defined as an SpO2 ≤ 90% on 6 liters of oxygen or FiO2 of 40% at the time of randomization, but they will only be extubated after correction of this hypoxemia. In practice, patients in the conventional extubation group are not extubated after randomization and continue on invasive ventilation. A new spontaneous breathing trial (SBT) can be performed between 2 and 6 hours after randomization, and if unsuccessful, it may be repeated daily at the discretion of the clinician. Patients in the conventional extubation group will only be extubated when their SpO2 exceeds 90% during an SBT conducted on 6 liters of oxygen or FiO2 of 40%. After extubation, a non-invasive oxygenation strategy will be initiated, alternating between non-invasive ventilation (NIV) and high-flow oxygen therapy, for a minimum of 24 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to ventilatory weaning
Time in hours from randomization to discontinuation of ventilatory support (invasive and non-invasive).
Measured: from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomization
Secondary outcomes (14)
neuromyopathie score
MRC score assessed in each group on day 7 of randomisation and on the day of weaning from non-invasive ventilation.
Measured: day 7of randomisation/day of weaning from non-invasive ventilation
death
occuring of death during ICU, hospital management and at day 90
Measured: at 28 and 90 days after randomisation
ventilatory support duration between randomization and day 28
Number of days alive without ventilation (invasive or non-invasive) at day 28 of randomization.
Measured: from randomisation to day 28
invasive ventilation duration
Time in hours between randomization and cessation of invasive ventilation
Measured: from date of randomisation until the date of cessation of invasive ventilation or death from any cause whichever came first assessed up to 90 days after randomization
non invasive ventilation duration
Time in hours between initiation and cessation of non-invasive support after extubation
Measured: from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days
reintubation rate
Number of patients requiring reintubation
Measured: up to day 90 after randomisation
Rate of ventilator-associated pneumonia.
Episodes of ventilator-associated pneumonia according to specific definition
Measured: up to day 90 after randomisation
Rate of pneumonia not acquired under invasive mechanical ventilation
Epiodes of pneumonia not acquired during invasive mechanical ventilation
Measured: up to 90 days after randomisation
time to mobilisation
time in hours between randomization and the first mobilisation in the chair
Measured: from date of randomisation until the date of the first chair mobilization or death from any cause whichever came first , assessed up to 90 days after randomization
time to ambulation
time in hours between randomization and first ambulation
Measured: from date of randomisation until the date of the first ambulation or death from any cause whichever came first , assessed up to 90 days after randomization
length of stay in ICU
number of day between admission and discharge to ICU
Measured: from date of entrance until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in ICU after randomisation
number of day between randomisation and discharge from the ICU
Measured: from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital after randomisation
Time in days from randomisation to hospital discharge
Measured: from date of randomisation until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital
number of day between admission to discharge of hospital
Measured: from date of admission until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start18 Nov 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688487
- Sponsor's protocol ID
- 2024-A00535-42
- Acronym
- EPHYRE
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
PubMed 25980660Quintard H, l'Her E, Pottecher J, Adnet F, Constantin JM, De Jong A, Diemunsch P, Fesseau R, Freynet A, Girault C, Guitton C, Hamonic Y, Maury E, Mekontso-Dessap A, Michel F, Nolent P, Perbet S, Prat G, Roquilly A, Tazarourte K, Terzi N, Thille AW, Alves M, Gayat E, Donetti L. Experts' guidelines of intubation and extubation of the ICU patient of French Society of Anaesthesia and Intensive Care Medicine (SFAR) and French-speaking Intensive Care Society (SRLF) : In collaboration with the pediatric Association of French-speaking Anaesthetists and Intensivists (ADARPEF), French-speaking Group of Intensive Care and Paediatric emergencies (GFRUP) and Intensive Care physiotherapy society (SKR). Ann Intensive Care. 2019 Jan 22;9(1):13. doi: 10.1186/s13613-019-0483-1.
PubMed 30671726Perkins GD, Mistry D, Gates S, Gao F, Snelson C, Hart N, Camporota L, Varley J, Carle C, Paramasivam E, Hoddell B, McAuley DF, Walsh TS, Blackwood B, Rose L, Lamb SE, Petrou S, Young D, Lall R; Breathe Collaborators. Effect of Protocolized Weaning With Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation From Mechanical Ventilation Among Patients With Respiratory Failure: The Breathe Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1881-1888. doi: 10.1001/jama.2018.13763.
PubMed 30347090
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Extubation in Hypoxemic ICU Patients: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06688487
- Acronym / sponsor ID
- EPHYRE / 2024-A00535-42
- Keywords
- extubation, hypoxemia, postoperative respiratory complication, weaning, facilitative non invasive strategy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 18 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 14 Nov 2024 (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.
The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:
Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).
Detailed description
International guidelines recommend extubating patients after correction of hypoxemia, meaning if the SpO2 measured during the spontaneous breathing trial is above 92%. However, there is strong rationale for modifying this practice to extubate patients earlier, particularly those presenting with hypoxemia after major surgery, by using alternating non-invasive ventilation (NIV) and high-flow oxygen therapy:
Several studies have found no link between patient oxygenation and extubation success, where outcomes for hypoxemic and non-hypoxemic patients are similar. Isolated hypoxemia thus does not appear to be a predictor of reintubation.
Hypoxemia is very common following major surgery, primarily due to shunts caused by atelectasis. Treatment for these atelectasis includes airway pressurization, bronchial secretion drainage, mobilization, and reducing factors that lead to diaphragmatic dysfunction.
In patients on invasive mechanical ventilation, secretion drainage is impaired, and mobilization to a seated position is more challenging. It has also been shown that diaphragmatic dysfunction occurs with prolonged ventilation. Hypoxemia can therefore be sustained by invasive ventilation, increasing the risk of therapeutic escalation.
Current guidelines do not account for the widespread use of non-invasive assistance techniques (such as high-flow oxygen therapy and non-invasive ventilation) that are now routinely employed in intensive care. These techniques allow for adequate oxygenation with high patient comfort and good tolerance.
Prolonging invasive ventilation in hypoxemic patients, as recommended by guidelines, could lead to associated complications. In contrast, early extubation of patients with hypoxemia may reduce the duration of both invasive and non-invasive ventilation, as well as complications related to prolonged invasive ventilation, without increasing the risk of reintubation.
Compared to continuing mechanical ventilation until hypoxemia is corrected, extubating purely hypoxemic patients and transitioning them to non-invasive ventilation techniques could represent a significant improvement in patient care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypoxemic extubation group | Experimental | Other: early extubation of hypoxemic patientsRandomized patients exhibit relative hypoxemia, defined by an SpO2 ≤ 90% while receiving 6 liters of oxygen or FiO2 of 40%. They must not have severe hypoxemia, defined as an SpO2 < 86% while receiving 9 liters of oxygen or FiO2 of 50%. Additionally, they must not show clinical signs of poor tolerance to the spontaneous breathing trial. Patients randomized to the "hypoxemic extubation group" are extubated despite the presence of relative hypoxemia after one hour of reventilation. Following extubation, a non-invasive oxygenation strategy is initiated, alternating between non-invasive ventilation and high-flow oxygen therapy for a minimum of 24 hours. |
| conventional extubation group | No intervention | –Patients in the conventional extubation group also present with relative hypoxemia, defined as an SpO2 ≤ 90% on 6 liters of oxygen or FiO2 of 40% at the time of randomization, but they will only be extubated after correction of this hypoxemia. In practice, patients in the conventional extubation group are not extubated after randomization and continue on invasive ventilation. A new spontaneous breathing trial (SBT) can be performed between 2 and 6 hours after randomization, and if unsuccessful, it may be repeated daily at the discretion of the clinician. Patients in the conventional extubation group will only be extubated when their SpO2 exceeds 90% during an SBT conducted on 6 liters of oxygen or FiO2 of 40%. After extubation, a non-invasive oxygenation strategy will be initiated, alternating between non-invasive ventilation (NIV) and high-flow oxygen therapy, for a minimum of 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Francophone patient affiliated to a health insurance plan;
- Patient having granted free, informed and written consent to participate in the study;
- Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L/min or FiO2 40% during spontaneous breathing trial.
Key exclusion criteria (16 listed)
- Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);
- Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L/min or FiO2 = 50%;
- Presence of poor clinical tolerance of SBT defined by polypnoea above 30/min, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;
- Presence of an ineffective cough or major bronchial congestion;
- Patient already included in a type 1 interventional research protocol (RIPH1), modifying the procedure for ventilatory weaning and/or ventilatory support after extubation;
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 |
|---|---|---|
| early extubation of hypoxemic patientspatient extubated after the spontaneous ventilation trial despite the presence of hypoxemia defined by SpO2 ≤ 90% either in T-piece under 6 L/min, or under FiO2 = 40% if SBT is performed in spontaneous ventilation with minimal inspiratory assistance. | Other | hypoxemic extubation group |
Primary outcome
time to ventilatory weaning
Time frame: from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomization
Time in hours from randomization to discontinuation of ventilatory support (invasive and non-invasive).
14 secondary outcomes
neuromyopathie score
Time frame: day 7of randomisation/day of weaning from non-invasive ventilation
death
Time frame: at 28 and 90 days after randomisation
ventilatory support duration between randomization and day 28
Time frame: from randomisation to day 28
invasive ventilation duration
Time frame: from date of randomisation until the date of cessation of invasive ventilation or death from any cause whichever came first assessed up to 90 days after randomization
non invasive ventilation duration
Time frame: from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days
reintubation rate
Time frame: up to day 90 after randomisation
Rate of ventilator-associated pneumonia.
Time frame: up to day 90 after randomisation
Rate of pneumonia not acquired under invasive mechanical ventilation
Time frame: up to 90 days after randomisation
time to mobilisation
Time frame: from date of randomisation until the date of the first chair mobilization or death from any cause whichever came first , assessed up to 90 days after randomization
time to ambulation
Time frame: from date of randomisation until the date of the first ambulation or death from any cause whichever came first , assessed up to 90 days after randomization
length of stay in ICU
Time frame: from date of entrance until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in ICU after randomisation
Time frame: from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital after randomisation
Time frame: from date of randomisation until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital
Time frame: from date of admission until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 25980660Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
- Background: PubMed 30671726Quintard H, l'Her E, Pottecher J, Adnet F, Constantin JM, De Jong A, Diemunsch P, Fesseau R, Freynet A, Girault C, Guitton C, Hamonic Y, Maury E, Mekontso-Dessap A, Michel F, Nolent P, Perbet S, Prat G, Roquilly A, Tazarourte K, Terzi N, Thille AW, Alves M, Gayat E, Donetti L. Experts' guidelines of intubation and extubation of the ICU patient of French Society of Anaesthesia and Intensive Care Medicine (SFAR) and French-speaking Intensive Care Society (SRLF) : In collaboration with the pediatric Association of French-speaking Anaesthetists and Intensivists (ADARPEF), French-speaking Group of Intensive Care and Paediatric emergencies (GFRUP) and Intensive Care physiotherapy society (SKR). Ann Intensive Care. 2019 Jan 22;9(1):13. doi: 10.1186/s13613-019-0483-1.
- Background: PubMed 30347090Perkins GD, Mistry D, Gates S, Gao F, Snelson C, Hart N, Camporota L, Varley J, Carle C, Paramasivam E, Hoddell B, McAuley DF, Walsh TS, Blackwood B, Rose L, Lamb SE, Petrou S, Young D, Lall R; Breathe Collaborators. Effect of Protocolized Weaning With Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation From Mechanical Ventilation Among Patients With Respiratory Failure: The Breathe Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1881-1888. doi: 10.1001/jama.2018.13763.
- 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early extubation of hypoxemic patients in people with Hypoxemia and Extubation, run by Fondation Hôpital Saint-Joseph at 12 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 16 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: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thibaut GENTY, M.D (0140942260, t.genty@gphsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to ventilatory weaning (time frame: from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomization). 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 NCT06688487, which also lists 3 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 Nov 2024.