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Optimeringsstrategi for akut tracheal intubation (OSETIM)

12. november 2026 opdateret af: University Hospital, Bordeaux

Effektiviteten af ​​en optimeringsstrategi for akut tracheal intubation på postintubationssygelighed: et cluster randomiseret kontrolleret forsøg

This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Several studies have reported positive impact of some interventions on the tracheal intubation-related complications incidence. Providing bag face-mask ventilation between medication administration and initiation of laryngoscopy significantly reduced the number of peri intubation hypoxemia episodes. The use of a non-depolarizing (rocuronium) paralytic agent instead of succinylcholine is associated with less post-intubation complications occurrence. Finally, use of a tracheal tube introducer (GEB) as an aid for intubation in emergency patients with at least one prognostic factor of difficult laryngoscopy has been shown to facilitate intubation. Assessment of a strategy combining these three interventions to reduce intubation related morbidity in emergency situations has never been assessed. It is expected that the combination of these interventions will drastically reduce the morbidity associated with emergency intubation. The strategy assessed will associate rocuronium use as paralyzing agent to facilitate intubation, bag mask ventilation before intubation and GEB use at first intubation attempt in all patients. The emergency physician in charge of the patients will record out-of hospital outcomes immediately after the out-of-hospital period. Intra-hospital data will be retrieved from the patient's medical record on the 28th day after inclusion.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Angers, Frankrig, 49933
      • Beaumont-sur-Oise, Frankrig, 95260
      • Bobigny, Frankrig, 93000
      • Bordeaux, Frankrig, 33000
        • Rekruttering
        • CHU de Bordeaux - Hôpital Pellegrin
        • Ledende efterforsker:
          • Xavier COMBES, PR
        • Kontakt:
      • Cergy-Pontoise, Frankrig, 95303
      • Créteil, Frankrig, 94000
      • Dijon, Frankrig, 21000
      • Eaubonne, Frankrig, 95600
      • Garches, Frankrig, 92380
      • La Tronche, Frankrig, 38700
        • Rekruttering
        • CHU de Grenoble - Hôpital Nord La Tronche
        • Kontakt:
      • Le Chesnay, Frankrig, 78157
        • Ikke rekrutterer endnu
        • CH de Versailles - Site André Mignot
        • Kontakt:
      • Lyon, Frankrig, 69003
      • Melun, Frankrig, 77000
      • Montpellier, Frankrig, 34000
      • Nantes, Frankrig, 44093
      • Paris, Frankrig, 75013
      • Paris, Frankrig, 75730
      • Paris, Frankrig, 75013
      • Poitiers, Frankrig, 86021
      • Saint-Pierre, Frankrig, 97448
      • Sélestat, Frankrig, 67 600
      • Toulouse, Frankrig, 31059

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient adult (≥ 18 years) presenting with vital distress requiring emergency tracheal intubation as assessed by the emergency physician in the out-of-hospital setting.
  • Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest will be included.

Exclusion Criteria:

  • Patient presenting of a contraindication to succinylcholine, and/or rocuronium, and/or sugammadex (rocunorium antagonist).
  • Patient who have contraindication to bag face mask ventilation before intubation (ongoing emesis, hematemesis, or hemoptysis).
  • Patient that are not members of a medical aid scheme (beneficiary or main member).
  • Patient under specific protection measures: pregnant, parturient or nursing women; legal protection or deprived of liberty: patient under judicial protection, patient under guardianship/curatorship.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment group

Combination rapid sequence intubation (RSI) with use of rocuronium and the bag-mask ventilation between induction and Gum Elastic Bougie GEB will be systematically used at the first attempt to facilitate intubation.
Andet: Data patient

Medical History and characteristic of patient

Andet: Physical examination

Arterial pressure, arterial oxygen saturation, heart rate

Procedure: Rapid sequence intubation (RSI) : Rocuronium /Bag-mask ventilation /GEB

Rapid sequence intubation (RSI) will be performed with use of rocuronium as paralytic agent (1.2 mg/ kg). Bag-mask ventilation between induction and laryngoscopy will be performed. The GEB will be systematically used at the first attempt to facilitate intubation.
Aktiv komparator: Control Group

Physicians will be reminded of the current recommendations for emergency intubation: Rapid sequence intubation (RSI) using succinylcholine and use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy.
Andet: Data patient

Medical History and characteristic of patient

Andet: Physical examination

Arterial pressure, arterial oxygen saturation, heart rate

Procedure: Rapid sequence intubation (RSI) : Recommendations for emergency intubation

Rapid sequence intubation (RSI) using succinylcholine as a paralytic agent (1 mg/kg), no systematic bag-mask ventilation between induction and laryngoscopy, use of GEB to facilitate intubation in case of intubation failure under direct laryngoscopy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severe intubation-related complications occurring during the first hour after intubation
Tidsramme: Day 0

Proportion of patients with severe intubation-related complications occurring during the first hour after intubation

The severe intubation-related complications are:

  • Cardiac arrest.
  • At least one arterial hypotension episode defined by systolic blood pressure<90 mmHg.
  • At least one hypoxemia episode defined by an occurrence of a new episode of oxygen.
  • Saturation < 90%.
  • Severe cardiac arrhythmia: ventricular tachycardia.
  • Pulmonary aspiration, reported by the physician.
  • Esophageal intubation.
  • Unintentional extubation. Severe intubation-related complications will be recorded by the emergency physician in charge of the patient.
Day 0

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difficulty of the intubation process - Intubation Difficulty
Tidsramme: Day 0

Intubation Difficulty Score (IDS). minimum values is 0 and the maximum values is dependent on the added elements.
Day 0
Difficulty of the intubation process - Intubation conditions assessed by the Copenhagen
Tidsramme: Day 0

Intubation conditions assessed by the Copenhagen score - The value is clinically not acceptable and clinical acceptable
Day 0
Difficulty of the intubation process - Alternative techniques.
Tidsramme: Day 0

Proportion of patients intubated by alternative techniques.
Day 0
Difficulty of the intubation process - Intubation attempts
Tidsramme: Day 0

Mean number of intubation attempts
Day 0
Difficulty of the intubation process - Intubation failures under direct laryngoscopy.
Tidsramme: Day 0

Mean number of intubation failures under direct laryngoscopy.
Day 0
Out-of hospital care -Time of out-of-hospital care
Tidsramme: Day 0

Mean time of out-of-hospital care (in minutes)
Day 0
Out-of hospital care - sedative drugs
Tidsramme: Day 0

Mean total amount of sedative drugs used after intubation
Day 0
Out-of hospital care - vasopressors
Tidsramme: Day 0

Mean total amount of vasopressors used after intubation
Day 0
Out-of hospital care : Mortality
Tidsramme: Day 0

Out-of-hospital mortality.
Day 0
Mortality
Tidsramme: Day 28

Vital status
Day 28

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Bordeaux

Efterforskere

  • Ledende efterforsker: Xavier COMBES, Pr, Université Hospital, Bordeaux

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. januar 2023

Primær færdiggørelse (Anslået)

14. september 2027

Studieafslutning (Anslået)

14. september 2027

Datoer for studieregistrering

Først indsendt

4. august 2022

Først indsendt, der opfyldte QC-kriterier

13. september 2022

Først opslået (Faktiske)

14. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUBX 2021/25

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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