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

12 september 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

401

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: 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.
Andere namen:
  • Bag-valve-mask ventilation
Actieve vergelijker: 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.
Ander: 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.
Andere namen:
  • Apnea

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Lowest arterial oxygen saturation
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sterfte in het ziekenhuis
Tijdsspanne: 28 dagen
28 dagen
Incidence of lowest oxygen saturation less than 90%
Tijdsspanne: 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%
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 24 hours after intubation
24 hours after intubation
Highest fraction of inspired oxygen in the 24 hours after intubation.
Tijdsspanne: 24 hours after intubation
24 hours after intubation
Highest positive end expiratory pressure in the 24 hours after intubation.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 48 hours after intubation
48 hours after intubation
New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
Tijdsspanne: 24 hours after intubation
24 hours after intubation
Incidence of esophageal intubation
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: One hour after intubation.
One hour after intubation.
Death within one hour of intubation
Tijdsspanne: One hour after intubation
One hour after intubation
Cormack-Lehane grade of glottic view
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University Medical Center

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 maart 2017

Primaire voltooiing (Werkelijk)

6 mei 2018

Studie voltooiing (Werkelijk)

6 juli 2018

Studieregistratiedata

Eerst ingediend

16 januari 2017

Eerst ingediend dat voldeed aan de QC-criteria

19 januari 2017

Eerst geplaatst (Schatting)

20 januari 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 september 2018

Laatste update ingediend die voldeed aan QC-criteria

12 september 2018

Laatst geverifieerd

1 september 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB #161962

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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