- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02497729
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial (Check-UP)
16 settembre 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
260
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama - Birmingham
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-
Louisiana
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New Orleans, Louisiana, Stati Uniti, 70115
- Ochsner Medical Center
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New Orleans, Louisiana, Stati Uniti, 70112
- Louisiana State University School of Medicine
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, Stati Uniti, 98104
- University of Washington
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Sniffing Position, No Checklist
Patient in the sniffing position without the use of a written checklist
|
|
Comparatore attivo: Sniffing Position, Checklist
Patient in the sniffing position with the use of a written checklist
|
Use of a written checklist pre and peri-intubation
Altri nomi:
|
Comparatore attivo: 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
Altri nomi:
|
Comparatore attivo: 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
Altri nomi:
Raising the patient's head of bed to 25 degrees
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Incidence of Desaturation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From enrollment through study day 28
|
Days alive and free from mechanical ventilation
|
From enrollment through study day 28
|
ICU-Free Days
Lasso di tempo: From enrollment through study day 28
|
Days alive and out of the ICU
|
From enrollment through study day 28
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Todd W Rice, MD, MSc, Vanderbilt University Medical Center
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2015
Completamento primario (Effettivo)
1 settembre 2016
Completamento dello studio (Effettivo)
1 settembre 2016
Date di iscrizione allo studio
Primo inviato
6 luglio 2015
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2015
Primo Inserito (Stima)
14 luglio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
19 settembre 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 settembre 2016
Ultimo verificato
1 settembre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 150897
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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