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Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)

16. september 2016 oppdatert av: Todd Rice, Vanderbilt University
The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.

Studietype

Intervensjonell

Registrering (Faktiske)

260

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama - Birmingham
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70115
        • Ochsner Medical Center
      • New Orleans, Louisiana, Forente stater, 70112
        • Louisiana State University School of Medicine
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • University of Washington

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Airway management events will be included in which:

  1. Patient is admitted to the Medical Intensive Care Unit (MICU)
  2. Planned procedure is endotracheal intubation
  3. Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
  4. Administration of sedation and/or neuromuscular blockade is planned
  5. Age ≥ 18 years old

Exclusion Criteria:

Airway management events will be excluded in which:

  1. Operator feels specific patient positioning during intubation is required
  2. Urgency of intubation precludes safe performance of study procedures
  3. Operator feels an alternative pre-procedure checklist or no checklist is required

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
Aktiv komparator: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
Fremgangsmåte: Written Checklist
Use of a written checklist pre and peri-intubation
Andre navn:
  • Sjekkliste
Aktiv komparator: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
Fremgangsmåte: Head of Bed Up
Raising the patient's head of bed to 25 degrees
Andre navn:
  • Patient Positioning
  • Sniff Position
Aktiv komparator: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
Fremgangsmåte: Written Checklist
Use of a written checklist pre and peri-intubation
Andre navn:
  • Sjekkliste
Fremgangsmåte: Head of Bed Up
Raising the patient's head of bed to 25 degrees
Andre navn:
  • Patient Positioning
  • Sniff Position

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Tidsramme: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
Time of Induction through 2 minutes after successful intubation
Lowest Systolic Blood Pressure (Checklist intervention only)
Tidsramme: Time of Induction through 2 minutes after successful intubation
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
Time of Induction through 2 minutes after successful intubation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Desaturation
Tidsramme: Time of Induction through 2 minutes after successful intubation
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
Time of Induction through 2 minutes after successful intubation
Incidence of Hypoxemia
Tidsramme: Time of Induction through 2 minutes after successful intubation
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
Time of Induction through 2 minutes after successful intubation
Change in Saturation
Tidsramme: Time of Induction through 2 minutes after successful intubation
Change in oxygen saturation from baseline to lowest oxygen saturation
Time of Induction through 2 minutes after successful intubation
Grade of First Glottic View
Tidsramme: Time of Induction through 2 minutes after successful intubation
Cormack-Lehane grade of view on first intubation attempt
Time of Induction through 2 minutes after successful intubation
First Pass Success
Tidsramme: Time of Induction through 2 minutes after successful intubation
Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
Time of Induction through 2 minutes after successful intubation
Number of Intubation Attempts
Tidsramme: Time of Induction through 2 minutes after successful intubation
Number of attempts required for successful tube placement
Time of Induction through 2 minutes after successful intubation
Time to Intubation
Tidsramme: Time of Induction through 2 minutes after successful intubation
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
Time of Induction through 2 minutes after successful intubation
Need for Assistance
Tidsramme: Time of Induction through 2 minutes after successful intubation
Incidence of need for additional intubating equipment, second operator
Time of Induction through 2 minutes after successful intubation
Non-hypoxic complications
Tidsramme: Time of Induction through 2 minutes after successful intubation
Incidence of non-oxygenation complications - composite of all other recorded complications
Time of Induction through 2 minutes after successful intubation
Malposition of Endotracheal Tube
Tidsramme: Time of Induction through 2 minutes after successful intubation
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
Time of Induction through 2 minutes after successful intubation
Repositioning Patient
Tidsramme: Time of Induction through 2 minutes after successful intubation
Incidence of repositioning patient after procedure initiation
Time of Induction through 2 minutes after successful intubation
In-Hospital Mortality
Tidsramme: From enrollment through the earlier of hospital discharge or 365 days
Death before hospital discharge
From enrollment through the earlier of hospital discharge or 365 days
Ventilator-free Days
Tidsramme: From enrollment through study day 28
Days alive and free from mechanical ventilation
From enrollment through study day 28
ICU-Free Days
Tidsramme: From enrollment through study day 28
Days alive and out of the ICU
From enrollment through study day 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vanderbilt University

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2015

Primær fullføring (Faktiske)

1. september 2016

Studiet fullført (Faktiske)

1. september 2016

Datoer for studieregistrering

Først innsendt

6. juli 2015

Først innsendt som oppfylte QC-kriteriene

10. juli 2015

Først lagt ut (Anslag)

14. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 150897

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