Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on postintubation Morbidity: A superiority cluster randomised controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

12 Jan 2023 → ongoing

Decision date (initial)

2024-09-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514913-37-00

EudraCT number

2022-002686-15

ClinicalTrials.gov

NCT05539391

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To estimate the effect of a combined strategy integrating rocuronium, bag face-mask ventilation before intubation and GEB e as an aid for tracheal intubation to the usual tracheal intubation process on early post-intubation related complications, in adult patients needing out-of hospital emergency tracheal intubation

Secondary objectives 1

1. To estimate the effect of a combined strategy integrating rocuronium, bag face-mask ventilation before intubation and GEB to the usual tracheal intubation process in adult patients needing out-of-hospital emergency tracheal intubation, on: intubation difficulty, out-of hospital care and mortality, 28-days mortality

Conditions and MedDRA coding

Respiratory distress

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult (≥ 18 years) patient presenting with vital distress needing an emergency endotracheal intubation , and treated by the participating SMUR
2. Patient with all conditions (trauma, dyspnea, coma, overdoses, and shock) except those in cardiac arrest

Exclusion criteria 4

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. proportion of patients with severe intubation-related complications occurring during the first hour after intubation. 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. Esophageal intubation. Unintentional extubation.

Secondary endpoints 10

1. Difficulty of the intubation process: Intubation Difficulty Score: Intubation Difficulty Score > 5 defining difficult intubation.18
2. Difficulty of the intubation process: Intubation conditions assessed by the Copenhagen score19: Poor conditions/Good conditions/Excellent conditions
3. Difficulty of the intubation process: Proportion of patients intubated by alternative techniques (stylet, gum elastic bougie, Intubating Laryngeal Mask Airway (ILMA) [e.g., Fastrach], or cricothyrotomy)
4. Difficulty of the intubation process: Mean number of intubation attempts
5. Difficulty of the intubation process: Mean number of intubation failures under direct laryngoscopy
6. Out-of hospital care: Mean time of out-of-hospital care (in minutes), defined from time of SMUR arrival on scene to time of hospitalization
7. Out-of hospital care: Mean total amount of sedative drugs used after intubation
8. Out-of hospital care: Mean total amount of vasopressors used after intubation
9. Out-of hospital care: Out-of-hospital mortality, defined as the proportion of patients who died during the out-of-hospital time
10. Mortality at 28 days: The follow-up of patients stopping at hospital admission, the vital status of the patient will be retrieved using the open-access French Register of deceased persons ("Fichier des personnes décédées") maintained by INSEE (website: https://deces.matchid.io/search)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Bordeaux

Sponsor organisation

Centre Hospitalier Universitaire De Bordeaux

Address

12 Rue Dubernat, Cs 91286 Cs 91286

City

Talence

Postcode

33400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Coordinating Investigator

Public contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Coordinating Investigator

Locations

1 EU/EEA country · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications