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

• 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: Vanderbilt University
• Information provided by (Responsible Party): David Janz, Vanderbilt University

Tracking Information

• First Submitted Date: January 27, 2014
• First Posted Date: January 31, 2014
• Results First Submitted Date: July 6, 2016
• Results First Posted Date: May 24, 2017
• Last Update Posted Date: May 24, 2017
• Study Start Date: February 2014
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Respiratory Failure

Intervention

• Device: Video Laryngoscopy
• Device: Apneic Oxygenation
• Device: Direct Laryngoscopy
• Device: No Apneic Oxygenation

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 30, 2014): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2015
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02051816
• Other Study ID Numbers: 131966
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David Janz, Vanderbilt University
• Study Sponsor: Vanderbilt University
• Collaborators: Not Provided

Investigators

• 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