NCT03420027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

January 28, 2018

Last Update Submit

June 7, 2019

Conditions

Keywords

predictive scoredifficult intubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse events

    30 min

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related 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; 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.

    PMID: 23348979BACKGROUND

Study Officials

  • Mai-Anh Nay, MD

    Centre Hospitalier régional d'Orléans, Orléans, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2018

First Posted

February 5, 2018

Study Start

March 1, 2018

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations