Trial Outcomes & Findings for The Use of Apneic Oxygenation During Prolonged Intubation in Pediatric Patients: a Randomized Clinical Trial (NCT NCT01886807)

Results Overview

In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome. From start of intubation attempt to completion of intubation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

482 participants

Primary outcome timeframe

From start of intubation attempt to completion of intubation, up to 1 hour

Results posted on

2019-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	(DL Group) direct laryngoscopy for nasotracheal intubation without oxygen insufflation	(DL-O2 Group) direct laryngoscopy for nasotracheal intubation with oxygen insufflation	(VL Group) nasotracheal intubation using the Truview PCD video laryngoscope
Overall Study STARTED	164	155	163
Overall Study COMPLETED	159	145	153
Overall Study NOT COMPLETED	5	10	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Apneic Oxygenation During Prolonged Intubation in Pediatric Patients: a Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(DL Group) n=159 Participants direct laryngoscopy for nasotracheal intubation without oxygen insufflation	(DL-O2 Group) n=145 Participants direct laryngoscopy for nasotracheal intubation with oxygen insufflation	(VL Group) n=153 Participants nasotracheal intubation using the Truview PCD video laryngoscope	Total n=457 Participants Total of all reporting groups
Age, Continuous	4.3 years STANDARD_DEVIATION 1.9 • n=5 Participants	4.4 years STANDARD_DEVIATION 2.1 • n=7 Participants	4.7 years STANDARD_DEVIATION 2.0 • n=5 Participants	4.5 years STANDARD_DEVIATION 2.0 • n=4 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	71 Participants n=7 Participants	72 Participants n=5 Participants	214 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	74 Participants n=7 Participants	81 Participants n=5 Participants	243 Participants n=4 Participants

PRIMARY outcome

Timeframe: From start of intubation attempt to completion of intubation, up to 1 hour

In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome. From start of intubation attempt to completion of intubation.

Outcome measures

Outcome measures
Measure	(DL Group) n=159 Participants direct laryngoscopy for nasotracheal intubation without oxygen insufflation TrueView PCD Video Laryngoscope	(DL-O2 Group) n=145 Participants direct laryngoscopy for nasotracheal intubation with oxygen insufflation TrueView PCD Video Laryngoscope	(VL Group) n=153 Participants nasotracheal intubation using the Truview PCD video laryngoscope TrueView PCD Video Laryngoscope
Time of Oxygen Saturation Change	30 seconds Interval 24.0 to 39.0	67 seconds Interval 35.0 to 149.0	75 seconds Interval 37.0 to 122.0

PRIMARY outcome

Timeframe: From beginning to end of laryngoscopy

Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )

Outcome measures

Outcome measures
Measure	(DL Group) n=159 Participants direct laryngoscopy for nasotracheal intubation without oxygen insufflation TrueView PCD Video Laryngoscope	(DL-O2 Group) n=145 Participants direct laryngoscopy for nasotracheal intubation with oxygen insufflation TrueView PCD Video Laryngoscope	(VL Group) n=153 Participants nasotracheal intubation using the Truview PCD video laryngoscope TrueView PCD Video Laryngoscope
Time to 1% Saturation Drop	30 seconds Interval 24.0 to 39.0	67 seconds Interval 35.0 to 149.0	75 seconds Interval 37.0 to 122.0

SECONDARY outcome

Timeframe: From start of intubation, up to 10 mins

Outcome measures

Outcome measures
Measure	(DL Group) n=159 Participants direct laryngoscopy for nasotracheal intubation without oxygen insufflation TrueView PCD Video Laryngoscope	(DL-O2 Group) n=145 Participants direct laryngoscopy for nasotracheal intubation with oxygen insufflation TrueView PCD Video Laryngoscope	(VL Group) n=153 Participants nasotracheal intubation using the Truview PCD video laryngoscope TrueView PCD Video Laryngoscope
Heart Rate	110 beats per minute Standard Deviation 27	114 beats per minute Standard Deviation 24	110 beats per minute Standard Deviation 26

SECONDARY outcome

Timeframe: From start of intubation attempt to completion of intubation, up to 10 mins

Outcome measures

Outcome measures
Measure	(DL Group) n=164 Participants direct laryngoscopy for nasotracheal intubation without oxygen insufflation TrueView PCD Video Laryngoscope	(DL-O2 Group) n=155 Participants direct laryngoscopy for nasotracheal intubation with oxygen insufflation TrueView PCD Video Laryngoscope	(VL Group) n=163 Participants nasotracheal intubation using the Truview PCD video laryngoscope TrueView PCD Video Laryngoscope
Systolic Blood Pressure	97 mmHG Standard Deviation 12	98 mmHG Standard Deviation 14	99 mmHG Standard Deviation 13

Adverse Events

(DL Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

(DL-O2 Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

(VL Group)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	(DL Group) n=164 participants at risk direct laryngoscopy for nasotracheal intubation without oxygen insufflation	(DL-O2 Group) n=155 participants at risk direct laryngoscopy for nasotracheal intubation with oxygen insufflation	(VL Group) n=163 participants at risk nasotracheal intubation using the Truview PCD video laryngoscope
Gastrointestinal disorders vomiting	0.00% 0/164	0.00% 0/155	1.8% 3/163 • Number of events 3

Additional Information

Dr. Jeffrey Steiner, PI

UTSouthwestern Medical Center

Phone: 214-456-0606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place