McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

Intratracheal Intubation in Critical Care Clinical Trial

— MACMAN  

Official title:

McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413723
• Other study ID #: 2014-A00674-43
• Status: Completed
• Phase: N/A
• First received: March 28, 2015
• Last updated: July 14, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Requiring orotracheal intubation

Exclusion Criteria:

• Contraindication to orotracheal intubation

• Time too short to allow inclusion and randomisation of patient (particularly cardiac arrest)

• Minor (<18 )

• Pregnant, parturient , or breast-feeding woman

• Patient hospitalized without consent and/or deprived of liberty by court's decision

• Patient under guardianship or curators

• Lack of social insurance

• Lack of informed consent

• Concomitant inclusion in a trial whose primary endpoint focuses on intubation procedure

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intratracheal Intubation in Critical Care

Intervention

Device:
• Videolaryngoscope
McGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation.
• Standard laryngoscope
Macintosh laryngoscope will be use for first attempt of intratracheal intubation.

Locations

Country	Name	City	State
France	CHU Louis Mourier	Colombes
France	CHD Vendee	La Roche Sur Yon
France	CHU Orleans	Orleans
France	CHU Paris Cochin	Paris
France	CHU Saint Louis	Paris
France	CHU Strasbourg Nouvel Hôpital Civil	Strasbourg
France	CHU Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee	Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cormack and Lehane grade		intubation procedure, an expected average of 15 minutes	No
Other	Percentage of glottic opening (POGO) score		intubation procedure, an expected average of 15 minutes	No
Other	Difficult Intubation		intubation procedure, an expected average of 15 minutes	No
Other	Resort to alternative intubation technique		intubation procedure, an expected average of 15 minutes	No
Other	Frequency of occurence of unexpected events		Discharge from Intensive Care unit, an expected average of 7 days	Yes
Other	Mechanical ventilation duration		Time from extubation, an expected average of 6 days	No
Other	Intensive Care Unit length of stay		Discharge from Intensive Care unit, an expected average of 7 days	No
Other	Hospital length of stay		Discharge from hospital, an expected average of 14 days	No
Other	Intensive Care Unit Mortality		Discharge from Intensive Care unit, an expected average of 7 days	Yes
Other	Mortality at day 28		Day 28	Yes
Primary	Proportion of successful orotracheal intubation at first laryngoscopy	Number of successful intubation at first laryngoscopy in one arm/number of included patients in the same arm.	intubation procedure, an expected average of 15 minutes	Yes
Secondary	Proportion of successful orotracheal intubation all laryngoscopies pooled		intubation procedure, an expected average of 15 minutes	Yes
Secondary	Time to successful orotracheal intubation	Defined by the time between the beginning of induction (injection of anesthetic drugs) and the time of confirmation of the intratracheal nature of the endotracheal tube (defined as apparition of first inflexion on the expired carbon dioxide curve)	intubation procedure, an expected average of 15 minutes	No