- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02497729
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
16 september 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
260
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama - Birmingham
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70115
- Ochsner Medical Center
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New Orleans, Louisiana, Förenta staterna, 70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, Förenta staterna, 98104
- University of Washington
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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:
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
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 |
---|---|
Inget ingripande: 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
|
Use of a written checklist pre and peri-intubation
Andra namn:
|
Aktiv komparator: Head of Bed Up, No Checklist
Patient with the head of bed up and without the use of a checklist
|
Raising the patient's head of bed to 25 degrees
Andra namn:
|
Aktiv komparator: Head of Bed Up, Checklist
Patient with the head of bed up and with the use of a checklist
|
Use of a written checklist pre and peri-intubation
Andra namn:
Raising the patient's head of bed to 25 degrees
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence of Desaturation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From enrollment through study day 28
|
Days alive and free from mechanical ventilation
|
From enrollment through study day 28
|
ICU-Free Days
Tidsram: From enrollment through study day 28
|
Days alive and out of the ICU
|
From enrollment through study day 28
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: 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
- 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.
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
1 juli 2015
Primärt slutförande (Faktisk)
1 september 2016
Avslutad studie (Faktisk)
1 september 2016
Studieregistreringsdatum
Först inskickad
6 juli 2015
Först inskickad som uppfyllde QC-kriterierna
10 juli 2015
Första postat (Uppskatta)
14 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 september 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2016
Senast verifierad
1 september 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 150897
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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