Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
16 september 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
260
Fase
- Fase 4
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
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Alabama
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Birmingham, Alabama, Verenigde Staten, 35294
- University of Alabama - Birmingham
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70115
- Ochsner Medical Center
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New Orleans, Louisiana, Verenigde Staten, 70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- University of Washington
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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:
Airway management events will be included in which:
- Patient is admitted to the Medical Intensive Care Unit (MICU)
- Planned procedure is endotracheal intubation
- Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
- Administration of sedation and/or neuromuscular blockade is planned
- Age ≥ 18 years old
Exclusion Criteria:
Airway management events will be excluded in which:
- Operator feels specific patient positioning during intubation is required
- Urgency of intubation precludes safe performance of study procedures
- Operator feels an alternative pre-procedure checklist or no checklist is required
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 |
|---|---|
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Geen tussenkomst: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
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Actieve vergelijker: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
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Use of a written checklist pre and peri-intubation
Andere namen:
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Actieve vergelijker: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
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Raising the patient's head of bed to 25 degrees
Andere namen:
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Actieve vergelijker: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
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Use of a written checklist pre and peri-intubation
Andere namen:
Raising the patient's head of bed to 25 degrees
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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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
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Time of Induction through 2 minutes after successful intubation
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Lowest Systolic Blood Pressure (Checklist intervention only)
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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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)
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Time of Induction through 2 minutes after successful intubation
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of Desaturation
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Incidence of Hypoxemia
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
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Time of Induction through 2 minutes after successful intubation
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Change in Saturation
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Change in oxygen saturation from baseline to lowest oxygen saturation
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Time of Induction through 2 minutes after successful intubation
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Grade of First Glottic View
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Cormack-Lehane grade of view on first intubation attempt
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Time of Induction through 2 minutes after successful intubation
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First Pass Success
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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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
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Time of Induction through 2 minutes after successful intubation
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Number of Intubation Attempts
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Number of attempts required for successful tube placement
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Time of Induction through 2 minutes after successful intubation
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Time to Intubation
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
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Time of Induction through 2 minutes after successful intubation
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Need for Assistance
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Incidence of need for additional intubating equipment, second operator
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Time of Induction through 2 minutes after successful intubation
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Non-hypoxic complications
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Incidence of non-oxygenation complications - composite of all other recorded complications
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Time of Induction through 2 minutes after successful intubation
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Malposition of Endotracheal Tube
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
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Time of Induction through 2 minutes after successful intubation
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Repositioning Patient
Tijdsspanne: Time of Induction through 2 minutes after successful intubation
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Incidence of repositioning patient after procedure initiation
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Time of Induction through 2 minutes after successful intubation
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In-Hospital Mortality
Tijdsspanne: From enrollment through the earlier of hospital discharge or 365 days
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Death before hospital discharge
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From enrollment through the earlier of hospital discharge or 365 days
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Ventilator-free Days
Tijdsspanne: From enrollment through study day 28
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Days alive and free from mechanical ventilation
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From enrollment through study day 28
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ICU-Free Days
Tijdsspanne: From enrollment through study day 28
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Days alive and out of the ICU
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From enrollment through study day 28
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: 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
- Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
- Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.
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
1 juli 2015
Primaire voltooiing (Werkelijk)
1 september 2016
Studie voltooiing (Werkelijk)
1 september 2016
Studieregistratiedata
Eerst ingediend
6 juli 2015
Eerst ingediend dat voldeed aan de QC-criteria
10 juli 2015
Eerst geplaatst (Schatting)
14 juli 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
19 september 2016
Laatste update ingediend die voldeed aan QC-criteria
16 september 2016
Laatst geverifieerd
1 september 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 150897
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