Trial Outcomes & Findings for Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children (NCT NCT02471521)

Results Overview

Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec

Results posted on

2019-01-31

Participant Flow

This single-center study was performed in a tertiary children's hospital in Republic of Korea.

Participant milestones

Participant milestones
Measure	Neuromuscular Blocker Group Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Non-neuromuscular Blocker Group Facemask ventilation was performed without rocuronium administration.
Overall Study STARTED	60	60
Overall Study COMPLETED	60	52
Overall Study NOT COMPLETED	0	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neuromuscular Blocker Group n=60 Participants Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Non-neuromuscular Blocker Group n=52 Participants Facemask ventilation was performed without rocuronium administration.	Total n=112 Participants Total of all reporting groups
Age, Continuous	1.2 years n=5 Participants	1.4 years n=7 Participants	1.3 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	31 Participants n=7 Participants	70 Participants n=5 Participants
Height	76.0 cm STANDARD_DEVIATION 14.3 • n=5 Participants	78.8 cm STANDARD_DEVIATION 14.2 • n=7 Participants	77.2 cm STANDARD_DEVIATION 14.5 • n=5 Participants
Weight	10.0 kg STANDARD_DEVIATION 3.8 • n=5 Participants	10.4 kg STANDARD_DEVIATION 3.5 • n=7 Participants	10.3 kg STANDARD_DEVIATION 3.7 • n=5 Participants

PRIMARY outcome

Timeframe: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec

Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation.

Outcome measures

Outcome measures
Measure	Neuromuscular Blocker Group n=60 Participants Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Non-neuromuscular Blocker Group n=52 Participants Facemask ventilation was performed without rocuronium administration.
Inspiratory Pressure That Cause Gastric Insufflation	13 cmH2O Interval 12.0 to 14.0	13 cmH2O Interval 12.0 to 14.0

SECONDARY outcome

Timeframe: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec

Outcome measures

Outcome measures
Measure	Neuromuscular Blocker Group n=60 Participants Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Non-neuromuscular Blocker Group n=52 Participants Facemask ventilation was performed without rocuronium administration.
Diagnostic Method That Detects Gastric Insufflation First Ultrasound	44 Participants	23 Participants
Diagnostic Method That Detects Gastric Insufflation First Auscultation	4 Participants	10 Participants
Diagnostic Method That Detects Gastric Insufflation First Simultaneous detection by both methods	12 Participants	19 Participants

Adverse Events

Neuromuscular Blocker Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-neuromuscular Blocker Group

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

Jin-Tae Kim

Seoul National University Hospital

Phone: 82-2-2072-3661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place