Trial Outcomes & Findings for Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study (NCT NCT02051816)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

1 hour

Results posted on

2017-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Video Laryngoscopy and No Apneic Oxygenation Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope. No Apneic Oxygenation	Direct Laryngoscopy and Apneic Oxygenation Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation	Video Laryngoscopy and 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 and No Apneic Oxygenation No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Direct Laryngoscopy
Overall Study STARTED	37	40	37	36
Overall Study COMPLETED	37	40	37	36
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Video Laryngoscopy and Apneic Oxygenation n=37 Participants 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	Direct Laryngoscopy and Apneic Oxygenation n=40 Participants 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	Video Laryngoscopy and no Apneic Oxygenation n=37 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope. and No apneic oxygenation	Direct Laryngoscopy and No Apneic Oxygenation n=36 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. and No apneic oxygenation	Total n=150 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 15 • n=5 Participants	58 years STANDARD_DEVIATION 14 • n=7 Participants	56 years STANDARD_DEVIATION 15 • n=5 Participants	58 years STANDARD_DEVIATION 12 • n=4 Participants	58 years STANDARD_DEVIATION 14 • n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	17 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants	59 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	21 Participants n=4 Participants	91 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	32 Participants n=4 Participants	125 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment United States	37 participants n=5 Participants	40 participants n=7 Participants	37 participants n=5 Participants	36 participants n=4 Participants	150 participants n=21 Participants
Body Mass Index	29 kg/m^2 STANDARD_DEVIATION 8 • n=5 Participants	29 kg/m^2 STANDARD_DEVIATION 9 • n=7 Participants	28 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	29 kg/m^2 STANDARD_DEVIATION 8 • n=4 Participants	29 kg/m^2 STANDARD_DEVIATION 8 • n=21 Participants
Acute Physiology and Chronic Health Evaluation II Score	21 units on a scale STANDARD_DEVIATION 9 • n=5 Participants	21 units on a scale STANDARD_DEVIATION 6 • n=7 Participants	23 units on a scale STANDARD_DEVIATION 6 • n=5 Participants	21 units on a scale STANDARD_DEVIATION 6 • n=4 Participants	21 units on a scale STANDARD_DEVIATION 7 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=74 Participants 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	Direct Laryngoscopy n=76 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=77 Participants 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 Apneic Oxygenation n=73 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
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.	51 participants	50 participants	NA participants See apneic oxygenation separate outcomes	NA participants See apneic oxygenation separate outcomes

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=74 Participants 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	Direct Laryngoscopy n=76 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=77 Participants 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 Apneic Oxygenation n=73 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
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).	NA percent arterial oxygen saturation See video laryngoscopy outcomes separately	NA percent arterial oxygen saturation See video laryngoscopy outcomes separately	92 percent arterial oxygen saturation Interval 84.0 to 99.0	90 percent arterial oxygen saturation Interval 80.0 to 96.0

SECONDARY outcome

Timeframe: 1 hour

Death within 1 hour of beginning the procedure

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=37 Participants 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	Direct Laryngoscopy n=40 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=37 Participants 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 Apneic Oxygenation n=36 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
Procedure-related Mortality	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Death from any cause in the ICU and at anytime after the procedure

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=37 Participants 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	Direct Laryngoscopy n=40 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=37 Participants 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 Apneic Oxygenation n=36 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
ICU-mortality	19 Participants	15 Participants	12 Participants	17 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=37 Participants 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	Direct Laryngoscopy n=40 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=37 Participants 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 Apneic Oxygenation n=36 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
Adjusted Lowest Arterial Oxygen Saturation During Procedure	88 PERCENT SATURATION Standard Deviation 12	89 PERCENT SATURATION Standard Deviation 12	87 PERCENT SATURATION Standard Deviation 12	82 PERCENT SATURATION Standard Deviation 16

SECONDARY outcome

Timeframe: 28 days

Number of days alive and free of mechanical ventilation after endotracheal intubation

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=37 Participants 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	Direct Laryngoscopy n=40 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=37 Participants 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 Apneic Oxygenation n=36 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
Ventilator-free Days	9 DAYS Standard Deviation 12	12 DAYS Standard Deviation 12	14 DAYS Standard Deviation 12	11 DAYS Standard Deviation 12

SECONDARY outcome

Timeframe: 1 hour

Number of esophageal intubations Per Study Group

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=37 Participants 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	Direct Laryngoscopy n=40 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=37 Participants 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 Apneic Oxygenation n=36 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
Number of Esophageal Intubations Per Group	0 number of esophageal intubations	1 number of esophageal intubations	1 number of esophageal intubations	3 number of esophageal intubations

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Video Laryngoscopy n=37 Participants 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	Direct Laryngoscopy n=40 Participants Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation	Apneic Oxygenation n=37 Participants 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 Apneic Oxygenation n=36 Participants No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy
Grade View of the Glottis	1.24 units on a scale Standard Deviation .43	1.8 units on a scale Standard Deviation 1.09	1.3 units on a scale Standard Deviation .66	1.75 units on a scale Standard Deviation .77

Adverse Events

Video Laryngoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Direct Laryngoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Apneic Oxygenation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Apneic Oxygenation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Janz, MD, MSc

LSU School of Medicine New Orleans

Phone: 504-568-3167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place