Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35294
- The University of Alabama at Birmingham
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70121
- Ochsner Health System
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New Orleans, Louisiana, Yhdysvallat, 70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville, Tennessee, Yhdysvallat, 37209
- Vanderbilt University Medical Center
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Washington
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Seattle, Washington, Yhdysvallat, 98104
- Harborview Medical Center, University of Washington
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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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.
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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.
Muut nimet:
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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.
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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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Lowest arterial oxygen saturation
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Sairaalakuolleisuus
Aikaikkuna: 28 päivää
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28 päivää
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Incidence of lowest oxygen saturation less than 90%
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 90% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80%
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Incidence of lowest oxygen saturation less than 80% in the time from induction to 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Change in saturation from induction to lowest oxygen saturation within 2 minutes after completion of the airway management procedure.
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of desaturation
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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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.
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Induction to 2 minutes after completion of the airway management procedure
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Lowest oxygen saturation in the 24 hours after intubation.
Aikaikkuna: 24 hours after intubation
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24 hours after intubation
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Highest fraction of inspired oxygen in the 24 hours after intubation.
Aikaikkuna: 24 hours after intubation
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24 hours after intubation
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Highest positive end expiratory pressure in the 24 hours after intubation.
Aikaikkuna: 24 hours after intubation
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24 hours after intubation
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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.
Aikaikkuna: 24 hours after intubation
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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.
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24 hours after intubation
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Operator-reported pulmonary aspiration
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Visualization of oropharyngeal or gastric contents in the pharynx, larynx, or trachea between induction and completion of airway management.
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Induction to 2 minutes after completion of the airway management procedure
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New infiltrate on chest imaging in the 48 hours after intubation
Aikaikkuna: 48 hours after intubation
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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
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48 hours after intubation
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Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
Aikaikkuna: 48 hours after intubation
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48 hours after intubation
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New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Aikaikkuna: 24 hours after intubation
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24 hours after intubation
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Incidence of esophageal intubation
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure (peri-procedural)
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Lowest systolic blood pressure between induction and two minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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New systolic blood pressure < 65 mmHg or new need for vasopressor between medication administration and 2 minutes following successful placement of an endotracheal tube
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Induction to 2 minutes after completion of the airway management procedure
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Cardiac arrest within one hour of intubation
Aikaikkuna: One hour after intubation.
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One hour after intubation.
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Death within one hour of intubation
Aikaikkuna: One hour after intubation
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One hour after intubation
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Cormack-Lehane grade of glottic view
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Operator-assessed difficulty of intubation
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Incidence of successful intubation on the first laryngoscopy attempt
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Number of laryngoscopy attempts
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Time from induction to successful intubation
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Need for additional airway equipment or a second operator
Aikaikkuna: Induction to 2 minutes after completion of the airway management procedure
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Induction to 2 minutes after completion of the airway management procedure
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Ventilator-free days
Aikaikkuna: 28 days
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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.
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28 days
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Intensive care unit-free days
Aikaikkuna: 28 days
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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.
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28 days
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Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Todd W Rice, MD, MSc, Vanderbilt University Medical Center
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
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Opiskelun aloitus (Todellinen)
Opiskelun aloitus
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Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
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Ensimmäinen toimitettu, joka täytti QC-kriteerit
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Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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