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

• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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

Outcome Measures

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.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video Laryngoscopy	Direct Laryngoscopy	Apneic Oxygenation	No Apneic Oxygenation
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).
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Video Laryngoscopy	Direct Laryngoscopy	Apneic Oxygenation	No Apneic Oxygenation
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
Description	Death within 1 hour of beginning the procedure
Time Frame	1 hour

Outcome Measure Data

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
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
Description	Death from any cause in the ICU and at anytime after the procedure
Time Frame	28 days

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Number of days alive and free of mechanical ventilation after endotracheal intubation
Time Frame	28 days

Outcome Measure Data

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
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
Description	Number of esophageal intubations Per Study Group
Time Frame	1 hour

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Video Laryngoscopy	Direct Laryngoscopy	Apneic Oxygenation	No Apneic Oxygenation
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	--/--	--/--	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: David Janz, MD, MSc
• Organization: LSU School of Medicine New Orleans
• Phone: 504-568-3167
• EMail: djanz@lsuhsc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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