Difficult Intubation in Intensive Care

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01816217
• Other study ID #: UF 8977
• Status: Terminated
• Phase: N/A
• First received: March 13, 2013
• Last updated: August 28, 2013
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cormack Grade Three/Four
• Difficult Intubation in ICU
• Strictly More Than Two Laryngoscopies

Intervention

Device:
• Intubation with The McGrath Mac videolaryngoscope

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Montpellier, Saint Eloi	Montpellier	Languedoc-Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of difficult intubation or/and Cormack 3-4		during the intubation	No
Secondary	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).	until 28 days after intubation	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	The number of intubation attempts		during the intubation	No
Secondary	The glottic view		during the intubation	No
Secondary	The success rate		during the intubation	No