Clinical trial NCT01816217: Difficult Intubation in Intensive Care
Official title: Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Difficult Intubation in ICU
Strictly More Than Two Laryngoscopies
Cormack Grade Three/Four
Keywords: Difficult intubation
Complications
Intensive care units
Videolaryngoscope
Laryngoscopy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed to compare a new videolaryngoscope called " McGrath Mac Video Laryngoscope" vs standard Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4 rates in a prospective interventional study.The present study was conducted to test the hypothesis that the implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.

Detailed description: We planned to evaluate in a prospective before-after study performed in a single 16-beds medical-surgical ICU in a teaching hospital that an implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.During the two periods of the study (non-interventional vs interventional), we planned to evaluate 280 intubations. In the non-interventional phase, all intubations will be performed as the standard of care of the unit using the standard Macintosh laryngoscope for intubation procedure. For this period, 140 intubations will be evaluated and will be considered as a "control" group. After an inter-phase of training on manikin of 6 weeks with the new McGrath mac videolaryngoscope, the "interventional phase will started in aim to include 140 intubations with the McGrath Mac videolaryngoscope.

An intermediate analysis was planned after 70 intubations with McGrath mac videolaryngoscope to assess safety (severe life-threatening complications) and difficult intubation rate and/or Cormack 3-4.Taking into account this intermediate analysis, the number of subjects needed was of 280.

An intubation will be defined as difficult in case of more than two laryngoscopies.

The MACOCHA score and the usual risks factors associated with difficult intubation in operative rooms will be assessed: past difficult intubation, Mallampati score, thyromental distance, mouth opening, neck circumference, upper lip bite test, neck extension, sleep apnea, facial disease.

The following parameters will be recorded: admission diagnosis, age, sex, body mass index, indication for intubation, comorbidities, hour of intubation, SAPS (Simplified Acute Physiologic Score) II score, SOFA (Sequential Organ Failure Assessment) score, skill level of operator,, number of operators, medications used and corresponding doses, equipment used, number of attempts and airway management techniques, head and body position, use of a cricoid pressure.

The complications during intubation will be evaluated:

* respiratory (aspiration, esophageal intubation, saturation less than 80%),
* hemodynamic (systolic arterial pressure less than 65mmHg, high cardiac frequency (more than 150 beats/min) or low cardiac frequency (less than 50 beats/min), arythmias, cardiac arrest),
* neurologic (agitation),
* local (dental injury, airway trauma),
* death.

The complication in the hour following the intubation will be also assessed:

* respiratory: major desaturation (saturation less than 80%, pneumothorax, persistant hypoxia with a saturation less than 80%,
* hemodynamic (persistent hypotension: systolic arterial pressure less than 90mmHg in spite of vascular loading of 500mL of cristalloid solution or 250ml of colloid solution, rythm trouble, cardiac arrest, introduction or increase of vasopressors),
* neurologic (agitation),
* death. Finally, a follow up of 28 days will be done (patient alive at 28 days, or date of death).

Eligibility criteria: Inclusion Criteria:

* Patient informed,
* Affiliated or benefit from a disease insurance regimen
* Available for a 28 days follow-up
* Men and women aged aged from at least 18 years
* Indication of intubation in ICU

Exclusion Criteria:

* Protected patient
* Opposition for study participation

Primary outcomes:
measure: The incidence of difficult intubation or/and Cormack 3-4
timeFrame: during the intubation
Secondary outcomes:
measure: The severe life-threatening complications related to intubation in ICU
timeFrame: until 28 days after intubation
measure: The moderate complications related to intubation in ICU
timeFrame: until 28 days after intubation
measure: The success rate of intubation on the first attempt
timeFrame: during the intubation
measure: The number of intubation attempts
timeFrame: during the intubation
measure: The glottic view
timeFrame: during the intubation
measure: The success rate
timeFrame: during the intubation
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi
state: Languedoc-Roussillon
Study officials:
affiliation: Anesthesiology and Critical Care Medicine of CHU of Montpellier
name: Samir SJ JABER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: