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The interim analysis has shown a significative difference between the two groups of patients.
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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:
The complication in the hour following the intubation will be also assessed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intubated patient | Experimental | Adult intubated in Intensive Care Unit (ICU) with The McGrath Mac videolaryngoscope (intervention described) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation with The McGrath Mac videolaryngoscope | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of difficult intubation or/and Cormack 3-4 | during the intubation |
| Measure | Description | Time Frame |
|---|---|---|
| The severe life-threatening complications related to intubation in ICU | Severe life-threatening complications are defined as death, cardiac arrest, severe cardiovascular collapse, defined as systolic blood pressure<65 mm Hg recorded at least one time and/or <90 mm Hg that lasted 30min despite 500-1,000 ml of fluid loading (crystalloids/or colloids solutions) and/or requiring introduction of vasoactive support, or severe hypoxemia (decrease in SpO2 below 80% during attempts). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir SJ JABER, MD, PhD | Anesthesiology and Critical Care Medicine of CHU of Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Montpellier, Saint Eloi | Montpellier | Languedoc-Roussillon | 34295 | France |
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| ID | Term |
|---|---|
| D007440 | Intubation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| until 28 days after intubation |
| The moderate complications related to intubation in ICU | Mild to moderate complications are defined as esophageal intubation, aspiration of gastric contents (migration of stomach contents into the lung, supraventricular and/or ventricular arrhythmia (without pulseless rhythm) that require therapy, dangerous agitation (Richmond Agitation-Sedation Scale (RASS) score above 3) or dental injury. | until 28 days after intubation |
| The success rate of intubation on the first attempt | An intubation attempt is defined as the introduction of the endotracheal tube past the patient's teeth or as a laryngoscopic failure without the introduction of the endotracheal tube. A laryngoscopic blade readjustment counts as a single attempt. | during the intubation |
| The number of intubation attempts | during the intubation |
| The glottic view | during the intubation |
| The success rate | during the intubation |