Acute Hypoxemic Respiratory FailurePFOXNCT06198504
Impact of End-tidal Oxygen Monitoring During Preoxygenation Before Intubation for Acute Hypoxemic Respiratory Failure in ICU Setting
A study testing Protocol using end-tidal oxygen monitoring during preoxygenation before intubation in people with Acute Hypoxemic Respiratory Failure, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
The main objective of this pilot study is to determine if our protocole using EtO2 monitoring during preoxygenation before intubation is feasible in a population of critically ill patients in acute hypoxemic respirator failure (AHRF) in Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Protocol using end-tidal oxygen monitoring during preoxygenation before intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2024to 1 May 2025
- 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
- Admitted in ICU
- In AHRF, defined as : respiratory rate greater than 25 breaths per minute or signs of respiratory distress, and a partial pressure of oxygen (PaO2) to FiO2 ratio equal to or below 200 mmHg (calculation of estimated FiO2 under standard oxygen as follows: FiO2 = 0.21 + oxygen flow rate × 0.03).
- Indication to intubate based on physician judgment
- Written consent obtained from the patient, relative, or emergency consent.
Who cannot join
- Contraindications to NIV (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures)
- Severe haemodynamic failure (Norepinephrine ≥ 0.3 μg/kg/min to maintain MAP ≥ 65 mmHg) or cardiac arrest
- Do not intubate order
- Pregnancy
- breastfeeding
- Refusal to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital Grenoble
Grenoble, 38043
Florian SIGAUD, 0476768076, fsigaud@chu-grenoble.fr
Amel REFES, 0476767109, arefes@chu-grenoble.fr
University Hospital Lyon
Lyon, 69002
Jean-Christophe RICHARD, 0426109272, j-christophe.richard@chu-lyon.fr
About this study
Official title: Impact of End-tidal Oxygen Monitoring During Preoxygenation Before Intubation for Acute Hypoxemic Respiratory Failure in ICU Setting: The PFOX Pilot Study.
The main objective of this pilot study is to determine if our protocole using EtO2 monitoring during preoxygenation before intubation is feasible in a population of critically ill patients in acute hypoxemic respirator failure (AHRF) in Intensive Care Unit (ICU).
We hypothesize that using EtO2 monitoring during preoxygenation before intubation is feasible and safe in a population of critically ill patients in AHRF in ICU setting.
Read the detailed description
Background : acute hypoxemic respiratory failure (AHRF) is one of the most common causes of intensive care unit (ICU) admission requiring subsequent tracheal intubation for invasive mechanical ventilation. Complications related to tracheal intubation are more frequent in ICU than in operating room with an incidence reaching 20 to 50% in previous studies. Among them, severe hypoxemia and hemodynamic failure can lead to cardiac arrest. End-expiratory tidal oxygen (EtO2) monitoring during preoxygenation is routinely used during anesthesia for elective surgery but has never been evaluated in ICU setting.
Objective : to evaluate the feasibility of a protocol using EtO2 monitoring during preoxygenation before intubation of patients in AHRF in ICU.
Methods : this is an interventional, prospective, bicenter (two French tertiary teaching Hospitals ICUs), feasibility study of a protocol using EtO2 monitoring during preoxygenation before rapid sequence induction (RSI) and intubation of patients in AHRF in ICU. Eligible patients will be older than 18 years, admitted to the ICU, requiring intubation, in AHRF according to the following criteria : a respiratory rate greater than 25 breaths per minute or signs of respiratory distress, and a partial pressure of arterial oxygen (PaO2) to FiO2 ratio equal to or below 200 mmHg (calculation of estimated FiO2 under standard oxygen as follows: FiO2 = 0.21 + oxygen flow rate × 0.03). Main exclusion criteria will be contraindications to Non Invasive Ventilation (NIV) (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), severe haemodynamic failure (Norepinephrine ≥ 0.3 μg/kg/min), cardiac arrest, do not intubate order, pregnancy or breastfeeding and refusal to participate. In 72 consecutive eligible patients tracheal intubation procedure will be performed in accordance with current guidelines except for the duration of the preoxygenation to be individualized by EtO2 monitoring. A targeted EtO2 ≥ 90% will trigger RSI and intubation. During the procedure, preoxygenation modalities and duration, achieved EtO2 level, conduction of the induction and intubation, minimum SpO2 and occurrence of complications will be recorded. A 100- point ponderated score elaborated by an independent expert committee based on literature and updated national guidelines (4,5) will evaluate recommendations adherence. A score ≥ 85 / 100 adjudicates a procedure matching with good practices guidelines. The primary outcome is the percentage tracheal intubation procedures performed in accordance with current good practices guidelines.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Protocol using end-tidal oxygen monitoring during preoxygenation before intubation
- Keywords
- Intensive Care Unit (ICU), Intubation, Preoxygenation, End-expiratory tidal oxygen (EtO2)
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol using end-tidal oxygen monitoring during preoxygenation before intubationProcedure or surgery
According to previous studies a target of EtO2 ≥ 90% is proposed to trigger RSI and intubation. If this target is judged impossible to achieve and/or there is an imperative need to interrupt the pre-oxygenation phase, the operator is free to continue the procedure according to current recommendations.
Before the start of the inclusions, a training session on the use of the module will be organized with a reminder of the recommendations.
During the procedure, preoxygenation modalities and duration, achieved EtO2 level, conduction of the induction and intubation, minimum SpO2 and occurrence of complications will be recorded.
The procedure will stop ten minutes after completion of the orotracheal intubation procedure (defined as inflation of the balloon,clinical and capnography control).
| Study group | Role | What they receive |
|---|---|---|
| Protocol using end-tidal oxygen monitoring during preoxygenation before intubation | Experimental | In 72 consecutive eligible patients tracheal intubation procedure will be performed in accordance with current guidelines except for the duration of the preoxygenation to be individualized by EtO2 monitoring. Receives: Procedure: Protocol using end-tidal oxygen monitoring during preoxygenation before intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of tracheal intubation procedures performed in accordance with current good practices guidelines (defined by an independent expert committee score ≥ 85 / 100).
Measured: 3 hours
Secondary outcomes (3)
Sequential hierarchical analysis of next criteria
- Rate of serious complications during procedure defined by following composite criteria : deep hypoxemia (defined by SpO2 < 80%), hemodynamic failure (defined by mean arterial pressure < 65 mmHg despite volume expansion or use of vasopressor), cardiac arrest, death.
- Rate of moderate complications during procedure defined by composite criteria : hypoxemia (defined by 80% ≤ SpO2 < 90%), difficult intubation (defined as two unsuccessful attempts at laryngoscopy), ventricular or supra-ventricular rhythm trouble, esophageal intubation, aspiration, dental damage.
Measured: 3 hours
Duration of preoxygenation
Measured: 10 minutes
Maximum EtO2 level achieved
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Florian SIGAUD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198504
- Sponsor's protocol ID
- 38RC22.0426
- Acronym
- PFOX
- Status last verified
- Aug 2023
- First submitted
- 26 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRea Network for the Frida-Rea Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.
PubMed 23348979Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
PubMed 28099321Quintard 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 30671726Baillard C, Depret F, Levy V, Boubaya M, Beloucif S. Incidence and prediction of inadequate preoxygenation before induction of anaesthesia. Ann Fr Anesth Reanim. 2014 Apr;33(4):e55-8. doi: 10.1016/j.annfar.2013.12.018. Epub 2014 Feb 24.
PubMed 24582112Samain E, Biard M, Farah E, Holtzer S, Delefosse D, Marty J. [Monitoring expired oxygen fraction in preoxygenation of patients with chronic obstructive pulmonary disease]. Ann Fr Anesth Reanim. 2002 Jan;21(1):14-9. doi: 10.1016/s0750-7658(01)00545-7. French.
PubMed 11878116Berry CB, Myles PS. Preoxygenation in healthy volunteers: a graph of oxygen "washin" using end-tidal oxygraphy. Br J Anaesth. 1994 Jan;72(1):116-8. doi: 10.1093/bja/72.1.116.
PubMed 8110535Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.
PubMed 8110546Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
PubMed 26556848Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
PubMed 19399574Caputo ND, Oliver M, West JR, Hackett R, Sakles JC. Use of End Tidal Oxygen Monitoring to Assess Preoxygenation During Rapid Sequence Intubation in the Emergency Department. Ann Emerg Med. 2019 Sep;74(3):410-415. doi: 10.1016/j.annemergmed.2019.01.038. Epub 2019 Mar 14.
PubMed 30879700Oliver M, Caputo ND, West JR, Hackett R, Sakles JC. Emergency physician use of end-tidal oxygen monitoring for rapidsequence intubation. J Am Coll Emerg Physicians Open. 2020 Sep 28;1(5):706-713. doi: 10.1002/emp2.12260. eCollection 2020 Oct.
PubMed 33145509Jaber S, Rolle A, Godet T, Terzi N, Riu B, Asfar P, Bourenne J, Ramin S, Lemiale V, Quenot JP, Guitton C, Prudhomme E, Quemeneur C, Blondonnet R, Biais M, Muller L, Ouattara A, Ferrandiere M, Saint-Leger P, Rimmele T, Pottecher J, Chanques G, Belafia F, Chauveton C, Huguet H, Asehnoune K, Futier E, Azoulay E, Molinari N, De Jong A; STYLETO trial group. Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients. Intensive Care Med. 2021 Jun;47(6):653-664. doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25.
PubMed 34032882
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of End-tidal Oxygen Monitoring During Preoxygenation Before Intubation for Acute Hypoxemic Respiratory Failure in ICU Setting: The PFOX Pilot Study.
- ClinicalTrials.gov ID
- NCT06198504
- Acronym / sponsor ID
- PFOX / 38RC22.0426
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- Intensive Care Unit (ICU), Intubation, Preoxygenation, End-expiratory tidal oxygen (EtO2)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 10 Jan 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 main objective of this pilot study is to determine if our protocole using EtO2 monitoring during preoxygenation before intubation is feasible in a population of critically ill patients in acute hypoxemic respirator failure (AHRF) in Intensive Care Unit (ICU).
We hypothesize that using EtO2 monitoring during preoxygenation before intubation is feasible and safe in a population of critically ill patients in AHRF in ICU setting.
Detailed description
Background : acute hypoxemic respiratory failure (AHRF) is one of the most common causes of intensive care unit (ICU) admission requiring subsequent tracheal intubation for invasive mechanical ventilation. Complications related to tracheal intubation are more frequent in ICU than in operating room with an incidence reaching 20 to 50% in previous studies. Among them, severe hypoxemia and hemodynamic failure can lead to cardiac arrest. End-expiratory tidal oxygen (EtO2) monitoring during preoxygenation is routinely used during anesthesia for elective surgery but has never been evaluated in ICU setting.
Objective : to evaluate the feasibility of a protocol using EtO2 monitoring during preoxygenation before intubation of patients in AHRF in ICU.
Methods : this is an interventional, prospective, bicenter (two French tertiary teaching Hospitals ICUs), feasibility study of a protocol using EtO2 monitoring during preoxygenation before rapid sequence induction (RSI) and intubation of patients in AHRF in ICU. Eligible patients will be older than 18 years, admitted to the ICU, requiring intubation, in AHRF according to the following criteria : a respiratory rate greater than 25 breaths per minute or signs of respiratory distress, and a partial pressure of arterial oxygen (PaO2) to FiO2 ratio equal to or below 200 mmHg (calculation of estimated FiO2 under standard oxygen as follows: FiO2 = 0.21 + oxygen flow rate × 0.03). Main exclusion criteria will be contraindications to Non Invasive Ventilation (NIV) (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), severe haemodynamic failure (Norepinephrine ≥ 0.3 μg/kg/min), cardiac arrest, do not intubate order, pregnancy or breastfeeding and refusal to participate. In 72 consecutive eligible patients tracheal intubation procedure will be performed in accordance with current guidelines except for the duration of the preoxygenation to be individualized by EtO2 monitoring. A targeted EtO2 ≥ 90% will trigger RSI and intubation. During the procedure, preoxygenation modalities and duration, achieved EtO2 level, conduction of the induction and intubation, minimum SpO2 and occurrence of complications will be recorded. A 100- point ponderated score elaborated by an independent expert committee based on literature and updated national guidelines (4,5) will evaluate recommendations adherence. A score ≥ 85 / 100 adjudicates a procedure matching with good practices guidelines. The primary outcome is the percentage tracheal intubation procedures performed in accordance with current good practices guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protocol using end-tidal oxygen monitoring during preoxygenation before intubation | Experimental | Procedure: Protocol using end-tidal oxygen monitoring during preoxygenation before intubationIn 72 consecutive eligible patients tracheal intubation procedure will be performed in accordance with current guidelines except for the duration of the preoxygenation to be individualized by EtO2 monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted in ICU
- In AHRF, defined as : respiratory rate greater than 25 breaths per minute or signs of respiratory distress, and a partial pressure of oxygen (PaO2) to FiO2 ratio equal to or below 200 mmHg (calculation of estimated FiO2 under standard oxygen as follows: FiO2 = 0.21 + oxygen flow rate × 0.03).
- Indication to intubate based on physician judgment
- Written consent obtained from the patient, relative, or emergency consent.
Key exclusion criteria (6 listed)
- Contraindications to NIV (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures)
- Severe haemodynamic failure (Norepinephrine ≥ 0.3 μg/kg/min to maintain MAP ≥ 65 mmHg) or cardiac arrest
- Do not intubate order
- Pregnancy
- breastfeeding
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 |
|---|---|---|
| Protocol using end-tidal oxygen monitoring during preoxygenation before intubationAccording to previous studies a target of EtO2 ≥ 90% is proposed to trigger RSI and intubation. If this target is judged impossible to achieve and/or there is an imperative need to interrupt the pre-oxygenation phase, the operator is free to continue the procedure according to current recommendations. Before the start of the inclusions, a training session on the use of the module will be organized with a reminder of the recommendations. During the procedure, preoxygenation modalities and duration, achieved EtO2 level, conduction of the induction and intubation, minimum SpO2 and occurrence of complications will be recorded. The procedure will stop ten minutes after completion of the orotracheal intubation procedure (defined as inflation of the balloon,clinical and capnography control). | Procedure or surgery | Protocol using end-tidal oxygen monitoring during preoxygenation before intubation |
Primary outcome
Percentage of tracheal intubation procedures performed in accordance with current good practices guidelines (defined by an independent expert committee score ≥ 85 / 100).
Time frame: 3 hours
3 secondary outcomes
Sequential hierarchical analysis of next criteria
Time frame: 3 hours
Duration of preoxygenation
Time frame: 10 minutes
Maximum EtO2 level achieved
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 23348979De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRea Network for the Frida-Rea Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.
- Background: PubMed 28099321Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
- 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 24582112Baillard C, Depret F, Levy V, Boubaya M, Beloucif S. Incidence and prediction of inadequate preoxygenation before induction of anaesthesia. Ann Fr Anesth Reanim. 2014 Apr;33(4):e55-8. doi: 10.1016/j.annfar.2013.12.018. Epub 2014 Feb 24.
- Background: PubMed 11878116Samain E, Biard M, Farah E, Holtzer S, Delefosse D, Marty J. [Monitoring expired oxygen fraction in preoxygenation of patients with chronic obstructive pulmonary disease]. Ann Fr Anesth Reanim. 2002 Jan;21(1):14-9. doi: 10.1016/s0750-7658(01)00545-7. French.
- Background: PubMed 8110535Berry CB, Myles PS. Preoxygenation in healthy volunteers: a graph of oxygen "washin" using end-tidal oxygraphy. Br J Anaesth. 1994 Jan;72(1):116-8. doi: 10.1093/bja/72.1.116.
- Background: PubMed 8110546Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.
- Background: PubMed 26556848Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
- Background: PubMed 19399574Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
- Background: PubMed 30879700Caputo ND, Oliver M, West JR, Hackett R, Sakles JC. Use of End Tidal Oxygen Monitoring to Assess Preoxygenation During Rapid Sequence Intubation in the Emergency Department. Ann Emerg Med. 2019 Sep;74(3):410-415. doi: 10.1016/j.annemergmed.2019.01.038. Epub 2019 Mar 14.
- Background: PubMed 33145509Oliver M, Caputo ND, West JR, Hackett R, Sakles JC. Emergency physician use of end-tidal oxygen monitoring for rapidsequence intubation. J Am Coll Emerg Physicians Open. 2020 Sep 28;1(5):706-713. doi: 10.1002/emp2.12260. eCollection 2020 Oct.
- Background: PubMed 34032882Jaber S, Rolle A, Godet T, Terzi N, Riu B, Asfar P, Bourenne J, Ramin S, Lemiale V, Quenot JP, Guitton C, Prudhomme E, Quemeneur C, Blondonnet R, Biais M, Muller L, Ouattara A, Ferrandiere M, Saint-Leger P, Rimmele T, Pottecher J, Chanques G, Belafia F, Chauveton C, Huguet H, Asehnoune K, Futier E, Azoulay E, Molinari N, De Jong A; STYLETO trial group. Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients. Intensive Care Med. 2021 Jun;47(6):653-664. doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25.
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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.
Florian SIGAUD principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol using end-tidal oxygen monitoring during preoxygenation before intubation in people with Acute Hypoxemic Respiratory Failure, run by University Hospital, Grenoble at 2 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian SIGAUD (0476768076, fsigaud@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of tracheal intubation procedures performed in accordance with current good practices guidelines (defined by an independent expert committee score ≥ 85 / 100). (time frame: 3 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 NCT06198504, which also lists 12 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 10 Jan 2024.