Difficult Intubation in Intensive Care

NCT ID: NCT01816217

Last Updated: 2013-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

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).

Conditions

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

Keywords

Difficult intubation; Complications; Intensive care units; Videolaryngoscope; Laryngoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Intubated patient

Adult intubated in Intensive Care Unit (ICU) with The McGrath Mac videolaryngoscope (intervention described)

Group Type: EXPERIMENTAL

Intubation with The McGrath Mac videolaryngoscope

Intervention Type: DEVICE

Interventions

Intubation with The McGrath Mac videolaryngoscope

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir SJ JABER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Critical Care Medicine of CHU of Montpellier

Locations

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, France

Countries

France

Other Identifiers

UF 8977

Identifier Type: -

Identifier Source: org_study_id