Intubation, IntratrachealE-MACNCT03420027
Prehospital and Emergency Feasibility of MACOCHA Score Assessment to Predict Difficult Tracheal Intubation
An observational study of Intubation, Intratracheal and Emergency Medicine, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal, Emergency Medicine
- What is being tested?
- questionnaire to be filled in by investigators
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 7 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient ≥ 18 yrs
- Patient who have to undergo rapid sequence tracheal intubation as judged by the Emergency Physician
Who cannot join
- Pregnancy
- Cardiac arrest of any cause as the indication for intubation
- Patient or next-of-kin declining participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intubation, Intratracheal, Emergency Medicine
- Being tested
- questionnaire to be filled in by investigators
- Keywords
- predictive score, difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire to be filled in by investigatorsOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Secondary outcomes (1)
Adverse events
occurrence of any adverse event during and 30 minutes after intubation
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Mar 2018
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh Nay, MD, Principal investigator, Centre Hospitalier régional d'Orléans, Orléans, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420027
- Sponsor's protocol ID
- CHRO-2017- 14
- Other IDs
- 2017-A02885-48 (IDRCB number)
- Acronym
- E-MAC
- Status last verified
- Jun 2019
- First submitted
- 28 Jan 2018
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23348979
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of the MACOCHA Score and Indication of Endotracheal Intubation in Prehospital and Emergency Room: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03420027
- Acronym / sponsor ID
- E-MAC / CHRO-2017- 14
- Conditions
- Intubation, Intratracheal, Emergency Medicine
- Keywords
- predictive score, difficult intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patient ≥ 18 yrs
- Patient who have to undergo rapid sequence tracheal intubation as judged by the Emergency Physician
Key exclusion criteria (3 listed)
- Pregnancy
- Cardiac arrest of any cause as the indication for intubation
- Patient or next-of-kin declining participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire to be filled in by investigatorsA 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 | Other | – |
Primary outcome
number of missing items of the MACOCHA score
Time frame: 5 minutes
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.
1 secondary outcome
Adverse events
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Background: PubMed 23348979De 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.
- Individual participant dataSharing planned: No
Related trials for Intubation, Intratracheal
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai-Anh Nay, MD principal investigator
Centre Hospitalier régional d'Orléans, Orléans, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubation, Intratracheal and Emergency Medicine, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of missing items of the MACOCHA score (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.