- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02051816
Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study (FELLOW)
19. april 2017 opdateret af: David Janz, Vanderbilt University
Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit
Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients.
Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this setting.
While there are many important components of successful airway management in critical illness, the maintenance of adequate arterial hemoglobin saturation from procedure initiation until endotracheal tube placement is paramount as desaturation is the most common factor associated with peri-intubation cardiac arrest and death.
Interventions that either shorten the duration of time required for tube placement or prolong the period before desaturation may be effective in improving outcome.
The high rate of complications and the lack of existing evidence regarding the efficacy of current airway management techniques in shortening the time to airway establishment or prolonging the time to desaturation mandates further investigation.
The primary hypothesis is that video laryngoscopy will be superior to direct laryngoscopy in successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care Medicine fellows after controlling for the operator's past number of procedures with the equipment used.
Also, the investigators hypothesize that the provision of apneic oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure) will result in a higher arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) compared to no apneic oxygenation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
150
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adults
- Medical ICU Patients
- Require endotracheal intubation
- Endotracheal intubation to be performed by Pulmonary/Critical Care Medicine Fellow
- Sedation and/or neuromuscular blockade is planned for the procedure
Exclusion Criteria:
- Operators other than Pulmonary/Critical Care Medicine Fellows
- The operator predetermines that the patient requires specific intubating equipment or oxygenation technique will be required for the safe performance of the procedure
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: VL and AO
Video laryngoscopy and apneic oxygenation
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Aktiv komparator: DL and AO
Direct Laryngoscopy and apneic oxygenation
|
|
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Aktiv komparator: VL and no AO
Video Laryngoscopy and no apneic oxygenation
|
|
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Aktiv komparator: DL and no AO
Direct Laryngoscopy and no apneic oxygenation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used.
Tidsramme: 1 hour
|
The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator's past number of procedures with the equipment used.
|
1 hour
|
|
Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death).
Tidsramme: 1 hour
|
The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death).
|
1 hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procedure-related Mortality
Tidsramme: 1 hour
|
Death within 1 hour of beginning the procedure
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1 hour
|
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ICU-mortality
Tidsramme: 28 days
|
Death from any cause in the ICU and at anytime after the procedure
|
28 days
|
|
Adjusted Lowest Arterial Oxygen Saturation During Procedure
Tidsramme: 1 hour
|
Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs.
|
1 hour
|
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Ventilator-free Days
Tidsramme: 28 days
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Number of days alive and free of mechanical ventilation after endotracheal intubation
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28 days
|
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Number of Esophageal Intubations Per Group
Tidsramme: 1 hour
|
Number of esophageal intubations Per Study Group
|
1 hour
|
|
Grade View of the Glottis
Tidsramme: 1 hour
|
Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt.
Higher grades on the 1-4 scale indicate worse glottic views.
|
1 hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Matthew W Semler, MD, Vanderbilt University
- Studiestol: Todd W Rice, MD, MSc, Vanderbilt University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2014
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
27. januar 2014
Først indsendt, der opfyldte QC-kriterier
30. januar 2014
Først opslået (Skøn)
31. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 131966
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .