Cormack Grade Three/Four Clinical Trial
Official title:
Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study
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.
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).
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Intervention Model: Single Group Assignment, Masking: Open Label