Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study
Intubation with The McGrath Mac videolaryngoscope
Résumé
Date de début de l'étude : 1 octobre 2011
Date à laquelle le premier participant a commencé l'étude.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).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.70 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Centre Hospitalier Universitaire Montpellier, Saint Eloi
Montpellier, FranceOuvrir Centre Hospitalier Universitaire Montpellier, Saint Eloi dans Google Maps