Impact of End-tidal Oxygen Monitoring During Preoxygenation Before Intubation for Acute Hypoxemic Respiratory Failure in ICU Setting

NCT06198504 | Unknown

• 1 other identifier: 38RC22.0426
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

Intensive Care Unit (ICU); Intubation; Preoxygenation; End-expiratory tidal oxygen (EtO2)

Outcome Measures

Primary Outcomes (1)

• Percentage of tracheal intubation procedures performed in accordance with current good practices guidelines (defined by an independent expert committee score ≥ 85 / 100).

  3 hours

Secondary Outcomes (3)

• Sequential hierarchical analysis of next criteria

  3 hours

• Duration of preoxygenation

  10 minutes

• Maximum EtO2 level achieved

  10 minutes

Study Arms (1)

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.

Procedure: Protocol using end-tidal oxygen monitoring during preoxygenation before intubation

Interventions

Protocol using end-tidal oxygen monitoring during preoxygenation before intubation PROCEDURE

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).

Protocol using end-tidal oxygen monitoring during preoxygenation before intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Philips Healthcare: collaborator

Study Sites (2)

University Hospital Grenoble

Grenoble, 38043, France

Location

University Hospital Lyon

Lyon, 69002, France

Location

Related Publications (12)

• 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.

  PMID: 23348979 BACKGROUND

• Nimmagadda 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.

  PMID: 28099321 BACKGROUND

• Quintard 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.

  PMID: 30671726 BACKGROUND

• Baillard 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.

  PMID: 24582112 BACKGROUND

• Samain 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.

  PMID: 11878116 BACKGROUND

• Berry 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.

  PMID: 8110535 BACKGROUND

• Campbell IT, Beatty PC. Monitoring preoxygenation. Br J Anaesth. 1994 Jan;72(1):3-4. doi: 10.1093/bja/72.1.3. No abstract available.

  PMID: 8110546 BACKGROUND

• Frerk 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.

  PMID: 26556848 BACKGROUND

• Tanoubi 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.

  PMID: 19399574 BACKGROUND

• Caputo 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.

  PMID: 30879700 BACKGROUND

• Oliver 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.

  PMID: 33145509 BACKGROUND

• Jaber 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.

  PMID: 34032882 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Florian SIGAUD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian SIGAUD

CONTACT

0476768076; fsigaud@chu-grenoble.fr

Amel REFES

CONTACT

0476767109; arefes@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 10, 2024

Record last verified: 2023-08

Locations

FR (2)