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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Respiratory Failure
Interventions Device: Video Laryngoscopy
Device: Apneic Oxygenation
Device: Direct Laryngoscopy
Device: No Apneic Oxygenation
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Period Title: Overall Study
Started 37 40 37 36
Completed 37 40 37 36
Not Completed 0 0 0 0
Arm/Group Title Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and no Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation Total
Hide Arm/Group Description

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

and

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

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

and

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

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

and

No apneic oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

and

No apneic oxygenation

Total of all reporting groups
Overall Number of Baseline Participants 37 40 37 36 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 40 participants 37 participants 36 participants 150 participants
58  (15) 58  (14) 56  (15) 58  (12) 58  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 37 participants 36 participants 150 participants
Female
15
  40.5%
17
  42.5%
12
  32.4%
15
  41.7%
59
  39.3%
Male
22
  59.5%
23
  57.5%
25
  67.6%
21
  58.3%
91
  60.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 37 participants 36 participants 150 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   8.1%
7
  17.5%
6
  16.2%
3
   8.3%
19
  12.7%
White
33
  89.2%
30
  75.0%
30
  81.1%
32
  88.9%
125
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.7%
3
   7.5%
1
   2.7%
1
   2.8%
6
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 40 participants 37 participants 36 participants 150 participants
37 40 37 36 150
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 37 participants 40 participants 37 participants 36 participants 150 participants
29  (8) 29  (9) 28  (5) 29  (8) 29  (8)
Acute Physiology and Chronic Health Evaluation II Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 37 participants 40 participants 37 participants 36 participants 150 participants
21  (9) 21  (6) 23  (6) 21  (6) 21  (7)
[1]
Measure Description: range of scale is minimum 0 - maximum 100 lower values describe less acute/chronic illness and more likely to survive higher values describe more acute/chronic illness and less likely to survive
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy Direct Laryngoscopy Apneic Oxygenation No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

Apneic Oxygenation

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

No Apneic Oxygenation

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

Video Laryngoscopy

Direct Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Video Laryngoscopy

Direct Laryngoscopy

Overall Number of Participants Analyzed 74 76 77 73
Measure Type: Number
Unit of Measure: participants
51 50 NA [1]  NA [1] 
[1]
See apneic oxygenation separate outcomes
2.Primary Outcome
Title 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).
Hide Description 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).
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy Direct Laryngoscopy Apneic Oxygenation No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

Apneic Oxygenation

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

No Apneic Oxygenation

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

Video Laryngoscopy

Direct Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Video Laryngoscopy

Direct Laryngoscopy

Overall Number of Participants Analyzed 74 76 77 73
Median (Inter-Quartile Range)
Unit of Measure: percent arterial oxygen saturation
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
92
(84 to 99)
90
(80 to 96)
[1]
See video laryngoscopy outcomes separately
3.Secondary Outcome
Title Procedure-related Mortality
Hide Description Death within 1 hour of beginning the procedure
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Overall Number of Participants Analyzed 37 40 37 36
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
4.Secondary Outcome
Title ICU-mortality
Hide Description Death from any cause in the ICU and at anytime after the procedure
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Overall Number of Participants Analyzed 37 40 37 36
Measure Type: Count of Participants
Unit of Measure: Participants
19
  51.4%
15
  37.5%
12
  32.4%
17
  47.2%
5.Secondary Outcome
Title Adjusted Lowest Arterial Oxygen Saturation During Procedure
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Overall Number of Participants Analyzed 37 40 37 36
Mean (Standard Deviation)
Unit of Measure: PERCENT SATURATION
88  (12) 89  (12) 87  (12) 82  (16)
6.Secondary Outcome
Title Ventilator-free Days
Hide Description Number of days alive and free of mechanical ventilation after endotracheal intubation
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Overall Number of Participants Analyzed 37 40 37 36
Mean (Standard Deviation)
Unit of Measure: DAYS
9  (12) 12  (12) 14  (12) 11  (12)
7.Secondary Outcome
Title Number of Esophageal Intubations Per Group
Hide Description Number of esophageal intubations Per Study Group
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Overall Number of Participants Analyzed 37 40 37 36
Measure Type: Number
Unit of Measure: number of esophageal intubations
0 1 1 3
8.Secondary Outcome
Title Grade View of the Glottis
Hide Description 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.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Video Laryngoscopy and No Apneic Oxygenation Direct Laryngoscopy and Apneic Oxygenation Video Laryngoscopy and Apneic Oxygenation Direct Laryngoscopy and No Apneic Oxygenation
Hide Arm/Group Description:

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

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

Video Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Direct Laryngoscopy

Overall Number of Participants Analyzed 37 40 37 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.24  (.43) 1.8  (1.09) 1.3  (.66) 1.75  (.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Video Laryngoscopy Direct Laryngoscopy Apneic Oxygenation No Apneic Oxygenation
Hide Arm/Group Description

Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.

Apneic Oxygenation

No Apneic Oxygenation

Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.

Apneic Oxygenation

No Apneic Oxygenation

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

Video Laryngoscopy

Direct Laryngoscopy

No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.

Video Laryngoscopy

Direct Laryngoscopy

All-Cause Mortality
Video Laryngoscopy Direct Laryngoscopy Apneic Oxygenation No Apneic Oxygenation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Video Laryngoscopy Direct Laryngoscopy Apneic Oxygenation No Apneic Oxygenation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/76 (0.00%)   0/77 (0.00%)   0/73 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Video Laryngoscopy Direct Laryngoscopy Apneic Oxygenation No Apneic Oxygenation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   0/76 (0.00%)   0/77 (0.00%)   0/73 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Janz, MD, MSc
Organization: LSU School of Medicine New Orleans
Phone: 504-568-3167
EMail: djanz@lsuhsc.edu
Layout table for additonal information
Responsible Party: David Janz, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02051816    
Other Study ID Numbers: 131966
First Submitted: January 27, 2014
First Posted: January 31, 2014
Results First Submitted: July 6, 2016
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017