- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03026322
Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)
12 septembre 2018 mis à jour par: Matthew Semler, Vanderbilt University Medical Center
Complications are common during endotracheal intubation of critically ill adults.
Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room.
Safety and efficacy data, however, are lacking.
PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary efficacy endpoint will be the lowest arterial oxygen saturation.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
PreVent is a prospective, parallel-group, pragmatic, randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults.
The primary aim of the PreVent trial is to compare the effect of manual ventilation between induction and intubation versus no manual ventilation on the lowest arterial oxygen saturation experienced by critically ill adults undergoing endotracheal intubation.
The PreVent trial is anticipated to begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation with sedation and/or neuromuscular blockade in participating units.
Patients will be randomized 1:1 to manual ventilation versus no manual ventilation.
In the manual ventilation group, manual ventilation using a bag-valve-mask will be provided from the time of induction until the time of endotracheal intubation, except during laryngoscopy.
In the no manual ventilation group, no manual ventilation will be provided between induction and endotracheal intubation, except for the treatment of hypoxemia.
The primary efficacy endpoint will be the lowest arterial oxygen saturation during the procedure.
The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure in the 24 hours after intubation.
Conduct of the trial will be overseen by a Data Safety Monitoring Board.
An interim analysis will be performed after the enrollment of 175 patients.
The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan made publicly available prior to the conclusion of enrollment.
The initial planned enrollment of 350 patients was increased by the Data and Safety Monitoring Board at the interim analysis to a final planned enrollment of 400 patients.
Type d'étude
Interventionnel
Inscription (Réel)
401
Phase
- N'est pas applicable
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
-
-
Alabama
-
Birmingham, Alabama, États-Unis, 35294
- The University of Alabama at Birmingham
-
-
Louisiana
-
New Orleans, Louisiana, États-Unis, 70121
- Ochsner Health System
-
New Orleans, Louisiana, États-Unis, 70112
- Louisiana State University School of Medicine
-
-
Tennessee
-
Nashville, Tennessee, États-Unis, 37209
- Vanderbilt University Medical Center
-
-
Washington
-
Seattle, Washington, États-Unis, 98104
- Harborview Medical Center, University of Washington
-
-
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:
- Patient is located in a participating unit
- Planned procedure is endotracheal intubation
- Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
- Urgency of intubation precludes safe performance of study procedures
- Operator feels a specific approach to ventilation between induction and intubation is required
- Pregnant women
- Prisoners
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 |
---|---|
Comparateur actif: Manual Ventilation
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
|
Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy.
In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
Autres noms:
|
Comparateur actif: No Manual Ventilation
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
|
Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%.
For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Lowest arterial oxygen saturation
Délai: Induction to 2 minutes after completion of the airway management procedure
|
The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Mortalité hospitalière
Délai: 28 jours
|
28 jours
|
|
Incidence of lowest oxygen saturation less than 90%
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
Incidence of lowest oxygen saturation less than 80%
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
Change in saturation from induction to lowest oxygen saturation
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
Incidence of desaturation
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Incidence of desaturation as defined by a decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
|
Induction to 2 minutes after completion of the airway management procedure
|
Lowest oxygen saturation in the 24 hours after intubation.
Délai: 24 hours after intubation
|
24 hours after intubation
|
|
Highest fraction of inspired oxygen in the 24 hours after intubation.
Délai: 24 hours after intubation
|
24 hours after intubation
|
|
Highest positive end expiratory pressure in the 24 hours after intubation.
Délai: 24 hours after intubation
|
24 hours after intubation
|
|
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
Délai: 24 hours after intubation
|
Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
|
24 hours after intubation
|
Operator-reported pulmonary aspiration
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
|
Induction to 2 minutes after completion of the airway management procedure
|
New infiltrate on chest imaging in the 48 hours after intubation
Délai: 48 hours after intubation
|
Determination of new infiltrate will be made by two blinded experts (pulmonary/critical care attendings or fellows) with adjudication by a third expert in the case of discordant results
|
48 hours after intubation
|
Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
Délai: 48 hours after intubation
|
48 hours after intubation
|
|
New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Délai: 24 hours after intubation
|
24 hours after intubation
|
|
Incidence of esophageal intubation
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Lowest systolic blood pressure (peri-procedural)
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
New systolic blood pressure < 65 mmHg or new need for vasopressor
Délai: Induction to 2 minutes after completion of the airway management procedure
|
New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
|
Induction to 2 minutes after completion of the airway management procedure
|
Cardiac arrest within one hour of intubation
Délai: One hour after intubation.
|
One hour after intubation.
|
|
Death within one hour of intubation
Délai: One hour after intubation
|
One hour after intubation
|
|
Cormack-Lehane grade of glottic view
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Operator-assessed difficulty of intubation
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Incidence of successful intubation on the first laryngoscopy attempt
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Number of laryngoscopy attempts
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Time from induction to successful intubation
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Need for additional airway equipment or a second operator
Délai: Induction to 2 minutes after completion of the airway management procedure
|
Induction to 2 minutes after completion of the airway management procedure
|
|
Ventilator-free days
Délai: 28 days
|
Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing.
If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28.
If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0. If a patient is discharged while receiving assisted ventilation, VFD will be 0. All data will be censored at the first of hospital discharge or 28 days.
|
28 days
|
Intensive care unit-free days
Délai: 28 days
|
ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit in that hospitalization before 28 days.
Patients who are never discharged from the intensive care unit will receive a value of 0. Patients who die before day 28 will receive a value of 0. For patients who return to an ICU and are subsequently discharged prior to day 28, ICU-free days will be counted from the date of final ICU discharge.
All data will be censored at the first of hospital discharge or 28 days.
|
28 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: 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
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
- Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.
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 (Réel)
15 mars 2017
Achèvement primaire (Réel)
6 mai 2018
Achèvement de l'étude (Réel)
6 juillet 2018
Dates d'inscription aux études
Première soumission
16 janvier 2017
Première soumission répondant aux critères de contrôle qualité
19 janvier 2017
Première publication (Estimation)
20 janvier 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 septembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 septembre 2018
Dernière vérification
1 septembre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB #161962
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .
Essais cliniques sur Manual Ventilation
-
Medical University of GdanskMinistry of Science and Higher Education, PolandInconnueInsuffisance respiratoirePologne