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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Device: Video Laryngoscopy Device: Apneic Oxygenation Device: Direct Laryngoscopy Device: No Apneic Oxygenation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: VL and AO
Video laryngoscopy and apneic oxygenation
Device: Apneic Oxygenation
Device: No Apneic Oxygenation
Active Comparator: DL and AO
Direct Laryngoscopy and apneic oxygenation
Device: Apneic Oxygenation
Device: No Apneic Oxygenation
Active Comparator: VL and no AO
Video Laryngoscopy and no apneic oxygenation
Device: Video Laryngoscopy
Device: Direct Laryngoscopy
Active Comparator: DL and no AO
Direct Laryngoscopy and no apneic oxygenation
Device: Video Laryngoscopy
Device: Direct Laryngoscopy



Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. Procedure-related Mortality [ Time Frame: 1 hour ]
    Death within 1 hour of beginning the procedure

  2. ICU-mortality [ Time Frame: 28 days ]
    Death from any cause in the ICU and at anytime after the procedure

  3. 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.

  4. Ventilator-free Days [ Time Frame: 28 days ]
    Number of days alive and free of mechanical ventilation after endotracheal intubation

  5. Number of Esophageal Intubations Per Group [ Time Frame: 1 hour ]
    Number of esophageal intubations Per Study Group

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051816


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Matthew W Semler, MD Vanderbilt University
Study Chair: Todd W Rice, MD, MSc Vanderbilt University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Janz, Clinical Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02051816    
Other Study ID Numbers: 131966
First Posted: January 31, 2014    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017
Last Verified: April 2017
Keywords provided by David Janz, Vanderbilt University:
Endotracheal Intubation
Apneic Oxygenation
Respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases