Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation

Intubation, Intratracheal Clinical Trial

— E-MAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420027
• Other study ID #: CHRO-2017- 14
• Secondary ID: 2017-A02885-48 (
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Medicine
• Intubation, Intratracheal

Intervention

Other:
• questionnaire to be filled in by investigators
A simple seven-item questionnaire will be filled in by the investigator before performing urgent tracheal intubation. This intubation, which will be performed as done in routine care, does not constitute a study specific intervention

Locations

Country	Name	City	State
France	CHR d'Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (1)

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; AzuRéa Network for the Frida-Réa 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	occurrence of any adverse event during and 30 minutes after intubation	30 min