Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation (E-MAC)

Evaluation of the Feasibility of the MACOCHA Score and Indication of Endotracheal Intubation in Prehospital and Emergency Room: a Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Emergency Medicine; Intubation, Intratracheal
• Intervention / Treatment: Other: questionnaire to be filled in by investigators

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.

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• France
  • Orléans, France, 45067
    • CHR d'Orléans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of missing items of the MACOCHA score	The MACOCHA score is a predictive score of difficult intubation in intensive care to anticipate and prepare the appropriate equipment, possibly use an alternative strategy of intubation and call for help to reduce the risk of morbidity and mortality. The MACOCHA score involves various simple assessment items: a Mallampati III or IV, a sleep apnea syndrome, a decrease in cervical mobility, a mouth opening <3cm, a coma defined by a Glasgow score <8, severe hypoxemia, and if the practitioner is not anesthetist. Missing items are defined as those for which relevant information cannot be collected before intubation.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	occurrence of any adverse event during and 30 minutes after intubation	30 min

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Mai-Anh Nay, MD, Centre Hospitalier régional d'Orléans, Orléans, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 7, 2019
• Study Completion (Actual): June 7, 2019

Study Registration Dates

• First Submitted: January 28, 2018
• First Submitted That Met QC Criteria: January 28, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 10, 2019
• Last Update Submitted That Met QC Criteria: June 7, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: difficult intubation; predictive score
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: CHRO-2017- 14; 2017-A02885-48 (IDRCB number) (Other Identifier: French Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No