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Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial (PreVent)

12 september 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

401

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • The University of Alabama at Birmingham
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70121
        • Ochsner Health System
      • New Orleans, Louisiana, Förenta staterna, 70112
        • Louisiana State University School of Medicine
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37209
        • Vanderbilt University Medical Center
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Harborview Medical Center, University of Washington

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Övrig: 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.
Andra namn:
  • Bag-valve-mask ventilation
Aktiv komparator: 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.
Övrig: 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.
Andra namn:
  • Apnea

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Lowest arterial oxygen saturation
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dödlighet på sjukhus
Tidsram: 28 dagar
28 dagar
Incidence of lowest oxygen saturation less than 90%
Tidsram: 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%
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 24 hours after intubation
24 hours after intubation
Highest fraction of inspired oxygen in the 24 hours after intubation.
Tidsram: 24 hours after intubation
24 hours after intubation
Highest positive end expiratory pressure in the 24 hours after intubation.
Tidsram: 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.
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 48 hours after intubation
48 hours after intubation
New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Tidsram: 24 hours after intubation
24 hours after intubation
Incidence of esophageal intubation
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: One hour after intubation.
One hour after intubation.
Death within one hour of intubation
Tidsram: One hour after intubation
One hour after intubation
Cormack-Lehane grade of glottic view
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Vanderbilt University Medical Center

Utredare

  • Huvudutredare: Todd W Rice, MD, MSc, Vanderbilt University Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 mars 2017

Primärt slutförande (Faktisk)

6 maj 2018

Avslutad studie (Faktisk)

6 juli 2018

Studieregistreringsdatum

Först inskickad

16 januari 2017

Först inskickad som uppfyllde QC-kriterierna

19 januari 2017

Första postat (Uppskatta)

20 januari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB #161962

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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