Clinical trial NCT03420027: Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation
Official title: Evaluation of the Feasibility of the MACOCHA Score and Indication of Endotracheal Intubation in Prehospital and Emergency Room: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation, Intratracheal
Emergency Medicine
Keywords: predictive score
difficult intubation
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be adult patients requiring emergent tracheal intubation for acute respiratory failure, coma, or shock, while cared for by an Emergency Physician either in the prehospital setting or in the hospital Emergency Department.

Brief summary: A seven-item simplified score (the MACOCHA score) has been validated to predict difficult tracheal intubation in intensive care unit patients. In the prehospital or in the emergency department settings, no such validated predictive score is available yet. The aim of the present study is to assess the feasibility the quick calculation of the MACOCHA score before emergent intubation, in the prehospital and emergency department contexts.

Detailed description: All patients who will have to undergo emergent tracheal intubation for any reason in the prehospital context or at the emergency department at a single 1100-bed regional and teaching hospital in France, will be included in this observational, prospective study, provided that neither the patient him/herself, if capable, or next-of-kin if present have declined participation.

Items of the MACOCHA score will be recorded before intubation by investigators, who are all certified emergency physicians skilled with urgent tracheal intubation.

For any intubation procedure, either in the out-of-hospital context or in the Emergency Department, one of these emergency physicians is always present.

The feasibility the quick MACOCHA score calculation before urgent intubation will be assessed by the number and percentages of patients for whom all the seven items of the score have been collected.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 yrs
* Patient who have to undergo rapid sequence tracheal intubation as judged by the Emergency Physician

Exclusion Criteria:

* Pregnancy
* Cardiac arrest of any cause as the indication for intubation
* Patient or next-of-kin declining participation

Primary outcomes:
measure: number of missing items of the MACOCHA score
timeFrame: 5 minutes
Secondary outcomes:
measure: Adverse events
timeFrame: 30 min
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orléans
Study officials:
affiliation: Centre Hospitalier régional d'Orléans, Orléans, France
name: Mai-Anh Nay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.