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Optimisation Strategy for Emergency Tracheal Intubation

NCT ID: NCT05539391

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-14

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emergencies Out-of-hospital Setting Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Data patient

Intervention Type OTHER

Medical History and characteristic of patient

Physical examination

Intervention Type OTHER

Arterial pressure, arterial oxygen saturation, heart rate

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

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Data patient

Intervention Type OTHER

Medical History and characteristic of patient

Physical examination

Intervention Type OTHER

Arterial pressure, arterial oxygen saturation, heart rate

Rapid sequence intubation (RSI) : Recommendations for emergency intubation

Intervention Type PROCEDURE

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.

Interventions

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Data patient

Medical History and characteristic of patient

Intervention Type OTHER

Physical examination

Arterial pressure, arterial oxygen saturation, heart rate

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier COMBES, Pr

Role: PRINCIPAL_INVESTIGATOR

Université Hospital, Bordeaux

Locations

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CHU d'Angers

Angers, , France

Site Status RECRUITING

CH Carnelle Portes de l'Oise

Beaumont-sur-Oise, , France

Site Status RECRUITING

AP-HP - Hôpital Avicenne

Bobigny, , France

Site Status RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

CH de Pontoise René Dubos

Cergy-Pontoise, , France

Site Status RECRUITING

AP-HP - Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

CHU de Dijon

Dijon, , France

Site Status NOT_YET_RECRUITING

GH Eaubonne Montmorency Hôpital Simone VEIL

Eaubonne, , France

Site Status RECRUITING

AP-HP - Hôpital Raymond Poincaré

Garches, , France

Site Status RECRUITING

CHU de Grenoble - Hôpital Nord La Tronche

La Tronche, , France

Site Status RECRUITING

CH de Versailles - Site André Mignot

Le Chesnay, , France

Site Status NOT_YET_RECRUITING

HCL - Hôpital Edouard Herriot

Lyon, , France

Site Status RECRUITING

GH Sud Ile de France

Melun, , France

Site Status RECRUITING

CHU de Montpellier Site Lapeyronie

Montpellier, , France

Site Status RECRUITING

CHU de Nantes - Hôpital Hôtel Dieu

Nantes, , France

Site Status RECRUITING

AP-HP - Hôpital Lariboisière

Paris, , France

Site Status RECRUITING

AP-HP - Hôpital Pitié-Salpétrière

Paris, , France

Site Status RECRUITING

AP-HP - Hôpital Necker

Paris, , France

Site Status RECRUITING

CHU Poitiers - Hôpital la Milétrie

Poitiers, , France

Site Status RECRUITING

CHU de la Réunion - site Sud

Saint-Pierre, , France

Site Status RECRUITING

GH Sélestat Obernai

Sélestat, , France

Site Status NOT_YET_RECRUITING

CHU Toulouse - Hôpital Purpan

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Xavier COMBES, Pr

Role: CONTACT

[email protected]
05 56 79 49 47 ext. 033

Facility Contacts

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Dominique SAVARY

Role: primary

[email protected]

Agnès Agnès RICARD-HIBON

Role: primary

[email protected]

Frédéric LAPOSTOLLE

Role: primary

[email protected]

Xavier COMBES, Pr

Role: primary

[email protected]

Agnès RICARD-HIBON

Role: primary

[email protected]

Charlotte CHOLLET-XEMARD

Role: primary

[email protected]

Patrick RAY

Role: primary

[email protected]

Laure GUILLOUX

Role: primary

[email protected]

Armelle SEVERIN

Role: primary

[email protected]

Guillaume DEBATY

Role: primary

[email protected]

Clotilde CAZENAVE

Role: primary

[email protected]

Marine PAUPE

Role: primary

[email protected]

Yousra GUETARI

Role: primary

[email protected]

Xavier BOBBIA

Role: primary

[email protected]

Quentin LE BASTARD

Role: primary

[email protected]

Xavier EYER

Role: primary

[email protected]

Patrick ECOLLAN

Role: primary

[email protected]

Thomas NICOL

Role: primary

[email protected]

Nicolas MARJANOVIC

Role: primary

[email protected]

Adrien MARTEAU

Role: primary

[email protected]

Gautier DROMSON

Role: primary

[email protected]

Bertrand GUIHARD

Role: primary

[email protected]

Other Identifiers

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CHUBX 2021/25

Identifier Type: -

Identifier Source: org_study_id

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