Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
Imethibitishwa Mwisho: | 08/31/2018 |
Iliyowasilishwa Kwanza: | 01/15/2017 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 01/18/2017 |
Iliyotumwa Kwanza: | 01/19/2017 |
Sasisho la Mwisho Liliwasilishwa: | 09/11/2018 |
Sasisho la Mwisho Lilichapishwa: | 09/12/2018 |
Tarehe halisi ya kuanza kwa masomo: | 03/14/2017 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 05/05/2018 |
Tarehe ya Kukamilisha Utafiti: | 07/05/2018 |
Hali au ugonjwa
Uingiliaji / matibabu
Other: Manual Ventilation
Other: No Manual Ventilation
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Active Comparator: 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. | Other: 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. |
Active Comparator: 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. | Other: 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. |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Lowest arterial oxygen saturation [Induction to 2 minutes after completion of the airway management procedure]
Hatua za Matokeo ya Sekondari
1. Incidence of lowest oxygen saturation less than 90% [Induction to 2 minutes after completion of the airway management procedure]
2. Incidence of lowest oxygen saturation less than 80% [Induction to 2 minutes after completion of the airway management procedure]
3. Change in saturation from induction to lowest oxygen saturation [Induction to 2 minutes after completion of the airway management procedure]
4. Incidence of desaturation [Induction to 2 minutes after completion of the airway management procedure]
5. Lowest oxygen saturation in the 24 hours after intubation. [24 hours after intubation]
6. Highest fraction of inspired oxygen in the 24 hours after intubation. [24 hours after intubation]
7. Highest positive end expiratory pressure in the 24 hours after intubation. [24 hours after intubation]
8. 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]
9. Operator-reported pulmonary aspiration [Induction to 2 minutes after completion of the airway management procedure]
10. New infiltrate on chest imaging in the 48 hours after intubation [48 hours after intubation]
11. Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome) [48 hours after intubation]
12. New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation [24 hours after intubation]
13. Incidence of esophageal intubation [Induction to 2 minutes after completion of the airway management procedure]
14. Lowest systolic blood pressure (peri-procedural) [Induction to 2 minutes after completion of the airway management procedure]
15. New systolic blood pressure < 65 mmHg or new need for vasopressor [Induction to 2 minutes after completion of the airway management procedure]
16. Cardiac arrest within one hour of intubation [One hour after intubation.]
17. Death within one hour of intubation [One hour after intubation]
18. Cormack-Lehane grade of glottic view [Induction to 2 minutes after completion of the airway management procedure]
19. Operator-assessed difficulty of intubation [Induction to 2 minutes after completion of the airway management procedure]
20. Incidence of successful intubation on the first laryngoscopy attempt [Induction to 2 minutes after completion of the airway management procedure]
21. Number of laryngoscopy attempts [Induction to 2 minutes after completion of the airway management procedure]
22. Time from induction to successful intubation [Induction to 2 minutes after completion of the airway management procedure]
23. Need for additional airway equipment or a second operator [Induction to 2 minutes after completion of the airway management procedure]
24. In-hospital mortality [28 days]
25. Ventilator-free days [28 days]
26. Intensive care unit-free days [28 days]