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Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study (FELLOW)

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ClinicalTrials.gov Identifier: NCT02051816
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
David Janz, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE January 27, 2014
First Posted Date  ICMJE January 31, 2014
Results First Submitted Date  ICMJE July 6, 2016
Results First Posted Date  ICMJE May 24, 2017
Last Update Posted Date May 24, 2017
Study Start Date  ICMJE February 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • 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. [ Time Frame: 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.
  • 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). [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Procedure-related Mortality [ Time Frame: 1 hour ]
    Death within 1 hour of beginning the procedure
  • ICU-mortality [ Time Frame: 28 days ]
    Death from any cause in the ICU and at anytime after the procedure
  • Adjusted Lowest Arterial Oxygen Saturation During Procedure [ Time Frame: 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.
  • Ventilator-free Days [ Time Frame: 28 days ]
    Number of days alive and free of mechanical ventilation after endotracheal intubation
  • Number of Esophageal Intubations Per Group [ Time Frame: 1 hour ]
    Number of esophageal intubations Per Study Group
  • Grade View of the Glottis [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • Procedure-related Mortality [ Time Frame: 1 hour ]
    Death within 1 hour of beginning the procedure
  • ICU-mortality [ Time Frame: 28 days ]
    Death from any cause in the ICU and at anytime after the procedure
  • Adjusted Lowest Arterial Oxygen Saturation During Procedure [ Time Frame: 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.
  • Ventilator-free Days [ Time Frame: 28 days ]
    Number of days alive and free of mechanical ventilation after endotracheal intubation
  • Number of Esophageal Intubations [ Time Frame: 1 hour ]
    Number of esophageal intubations during the procedure
  • Grade View of the Glottis [ Time Frame: 1 hour ]
    Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study
Official Title  ICMJE Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Failure
Intervention  ICMJE
  • Device: Video Laryngoscopy
  • Device: Apneic Oxygenation
  • Device: Direct Laryngoscopy
  • Device: No Apneic Oxygenation
Study Arms  ICMJE
  • Active Comparator: VL and AO
    Video laryngoscopy and apneic oxygenation
    Interventions:
    • Device: Apneic Oxygenation
    • Device: No Apneic Oxygenation
  • Active Comparator: DL and AO
    Direct Laryngoscopy and apneic oxygenation
    Interventions:
    • Device: Apneic Oxygenation
    • Device: No Apneic Oxygenation
  • Active Comparator: VL and no AO
    Video Laryngoscopy and no apneic oxygenation
    Interventions:
    • Device: Video Laryngoscopy
    • Device: Direct Laryngoscopy
  • Active Comparator: DL and no AO
    Direct Laryngoscopy and no apneic oxygenation
    Interventions:
    • Device: Video Laryngoscopy
    • Device: Direct Laryngoscopy
Publications * Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW; FELLOW Investigators; Pragmatic Critical Care Research Group. Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill. Am J Respir Crit Care Med. 2016 Feb 1;193(3):273-80. doi: 10.1164/rccm.201507-1294OC.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02051816
Other Study ID Numbers  ICMJE 131966
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Janz, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew W Semler, MD Vanderbilt University
Study Chair: Todd W Rice, MD, MSc Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP