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- Essai clinique NCT02497729
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
16 septembre 2016 mis à jour par: Todd Rice, Vanderbilt University
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Endotracheal intubation is common in the care of critically ill patients.
Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death.
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
Type d'étude
Interventionnel
Inscription (Réel)
260
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- University of Alabama - Birmingham
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Louisiana
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New Orleans, Louisiana, États-Unis, 70115
- Ochsner Medical Center
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New Orleans, Louisiana, États-Unis, 70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, États-Unis, 98104
- University of Washington
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Airway management events will be included in which:
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
Airway management events will be excluded in which:
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
|
|
Comparateur actif: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
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Use of a written checklist pre and peri-intubation
Autres noms:
|
Comparateur actif: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
|
Raising the patient's head of bed to 25 degrees
Autres noms:
|
Comparateur actif: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
|
Use of a written checklist pre and peri-intubation
Autres noms:
Raising the patient's head of bed to 25 degrees
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Délai: Time of Induction through 2 minutes after successful intubation
|
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
|
Time of Induction through 2 minutes after successful intubation
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Lowest Systolic Blood Pressure (Checklist intervention only)
Délai: Time of Induction through 2 minutes after successful intubation
|
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
|
Time of Induction through 2 minutes after successful intubation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence of Desaturation
Délai: Time of Induction through 2 minutes after successful intubation
|
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
|
Time of Induction through 2 minutes after successful intubation
|
Incidence of Hypoxemia
Délai: Time of Induction through 2 minutes after successful intubation
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Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
|
Time of Induction through 2 minutes after successful intubation
|
Change in Saturation
Délai: Time of Induction through 2 minutes after successful intubation
|
Change in oxygen saturation from baseline to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
|
Grade of First Glottic View
Délai: Time of Induction through 2 minutes after successful intubation
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Cormack-Lehane grade of view on first intubation attempt
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Time of Induction through 2 minutes after successful intubation
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First Pass Success
Délai: Time of Induction through 2 minutes after successful intubation
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Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
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Time of Induction through 2 minutes after successful intubation
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Number of Intubation Attempts
Délai: Time of Induction through 2 minutes after successful intubation
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Number of attempts required for successful tube placement
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Time of Induction through 2 minutes after successful intubation
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Time to Intubation
Délai: Time of Induction through 2 minutes after successful intubation
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Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
|
Time of Induction through 2 minutes after successful intubation
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Need for Assistance
Délai: Time of Induction through 2 minutes after successful intubation
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Incidence of need for additional intubating equipment, second operator
|
Time of Induction through 2 minutes after successful intubation
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Non-hypoxic complications
Délai: Time of Induction through 2 minutes after successful intubation
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Incidence of non-oxygenation complications - composite of all other recorded complications
|
Time of Induction through 2 minutes after successful intubation
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Malposition of Endotracheal Tube
Délai: Time of Induction through 2 minutes after successful intubation
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Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
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Time of Induction through 2 minutes after successful intubation
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Repositioning Patient
Délai: Time of Induction through 2 minutes after successful intubation
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Incidence of repositioning patient after procedure initiation
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Time of Induction through 2 minutes after successful intubation
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In-Hospital Mortality
Délai: From enrollment through the earlier of hospital discharge or 365 days
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Death before hospital discharge
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From enrollment through the earlier of hospital discharge or 365 days
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Ventilator-free Days
Délai: From enrollment through study day 28
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Days alive and free from mechanical ventilation
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From enrollment through study day 28
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ICU-Free Days
Délai: From enrollment through study day 28
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Days alive and out of the ICU
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From enrollment through study day 28
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Todd W Rice, MD, MSc, Vanderbilt University Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2015
Achèvement primaire (Réel)
1 septembre 2016
Achèvement de l'étude (Réel)
1 septembre 2016
Dates d'inscription aux études
Première soumission
6 juillet 2015
Première soumission répondant aux critères de contrôle qualité
10 juillet 2015
Première publication (Estimation)
14 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
19 septembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 septembre 2016
Dernière vérification
1 septembre 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 150897
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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