Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02471521
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 12.1

Study Details

Study Description

Brief Summary

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients.

The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.

For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

Condition or Disease	Intervention/Treatment	Phase
Child; Anesthesia	Other: Mask ventilation; Drug: Rocuronium	N/A

Detailed Description

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients.

The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. Stratum was constructed based on age and randomization scheme was performed separately within each stratum. Block randomization was done to ensure balance of the age groups.

For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.

For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

Tidal volume and oxygen saturation are recorded during study period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children: Study Using Detection of Gastric Insufflation Using Ultrasonography of the Antrum and Epigastric Auscultation
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neuromuscular blocker During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed with after rocuronium administration in children while continuous gastric auscultation and abdominal sonography are performed.	Other: Mask ventilation; Mask ventilation is performed after administration of rocuronium or not. Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.; Drug: Rocuronium; Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.
Active Comparator: Non-neuromuscular blocker During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed without rocuronium in children while continuous gastric auscultation and abdominal sonography are performed.	Other: Mask ventilation; Mask ventilation is performed after administration of rocuronium or not. Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.

Outcome Measures

Primary Outcome Measures

1. Inspiratory Pressure That Cause Gastric Insufflation [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.

Secondary Outcome Measures

1. Diagnostic Method That Detects Gastric Insufflation First [Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pediatric patients scheduled for elective surgery under general anesthesia

• BMI < 30

• ASA class 1 or 2

Exclusion Criteria:

• with difficult airway

• preexisting pulmonary disease

• upper respiratory tract infection

• intestinal obstruction

• with risk of pulmonary aspiration

• history of stoke or moyamoya disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jin-Tae Kim, MD. PhD., Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin-Tae Kim, associated professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02471521
• Other Study ID Numbers: H-1412-083-633
• First Posted: Jun 15, 2015
• Last Update Posted: Jan 31, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Respiratory Aspiration; Rocuronium

Study Results

Participant Flow

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

Arm/Group Title	Neuromuscular Blocker Group	Non-neuromuscular Blocker Group
Arm/Group Description	Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Facemask ventilation was performed without rocuronium administration.
Period Title: Overall Study
STARTED	60	60
COMPLETED	60	52
NOT COMPLETED	0	8

Baseline Characteristics

Arm/Group Title	Neuromuscular Blocker Group	Non-neuromuscular Blocker Group	Total
Arm/Group Description	Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Facemask ventilation was performed without rocuronium administration.	Total of all reporting groups
Overall Participants	60	52	112
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	1.2	1.4	1.3
Sex: Female, Male (Count of Participants)
Female	21 35%	21 40.4%	42 37.5%
Male	39 65%	31 59.6%	70 62.5%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	76.0 (14.3)	78.8 (14.2)	77.2 (14.5)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	10.0 (3.8)	10.4 (3.5)	10.3 (3.7)

Outcome Measures

1. Primary Outcome

Title	Inspiratory Pressure That Cause Gastric Insufflation
Description	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.
Time Frame	Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Neuromuscular Blocker Group	Non-neuromuscular Blocker Group
Arm/Group Description	Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Facemask ventilation was performed without rocuronium administration.
Measure Participants	60	52
Mean (Full Range) [cmH2O]	13	13

2. Secondary Outcome

Title	Diagnostic Method That Detects Gastric Insufflation First
Time Frame	Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Neuromuscular Blocker Group	Non-neuromuscular Blocker Group
Arm/Group Description	Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.	Facemask ventilation was performed without rocuronium administration.
Measure Participants	60	52
Ultrasound	44 73.3%	23 44.2%
Auscultation	4 6.7%	10 19.2%
Simultaneous detection by both methods	12 20%	19 36.5%

Adverse Events

Arm/Group Title	Neuromuscular Blocker Group		Non-neuromuscular Blocker Group
Arm/Group Description	Facemask ventilation was performed after rocuronium (0.6mg/kg) was administered.		Facemask ventilation was performed without rocuronium administration.
All Cause Mortality
	Neuromuscular Blocker Group		Non-neuromuscular Blocker Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/52 (0%)
Serious Adverse Events
	Neuromuscular Blocker Group		Non-neuromuscular Blocker Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Neuromuscular Blocker Group		Non-neuromuscular Blocker Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/52 (0%)

Limitations/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.