Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

NCT02471521 | Completed Results DMC

• 1 other identifier: H-1412-083-633
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Inspiratory Pressure That Cause Gastric Insufflation

  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.

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

Secondary Outcomes (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

Study Arms (2)

Neuromuscular blocker

EXPERIMENTAL

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; Drug: Rocuronium

Non-neuromuscular blocker

ACTIVE COMPARATOR

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

Interventions

Mask ventilation OTHER

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.

Neuromuscular blocker; Non-neuromuscular blocker

Rocuronium DRUG

Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.

Neuromuscular blocker

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients scheduled for elective surgery under general anesthesia
• BMI \< 30
• ASA class 1 or 2

You may not qualify if:

• with difficult airway
• preexisting pulmonary disease
• upper respiratory tract infection
• intestinal obstruction
• with risk of pulmonary aspiration
• history of stoke or moyamoya disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Lee JH, Jung H, Kim EH, Song IK, Kim HS, Kim JT. Optimal inspiratory pressure for face mask ventilation in paralyzed and unparalyzed children to prevent gastric insufflation: a prospective, randomized, non-blinded study. Can J Anaesth. 2018 Dec;65(12):1288-1295. doi: 10.1007/s12630-018-1183-2. Epub 2018 Jul 11.

  PMID: 29998359 DERIVED

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jin-Tae Kim
• Organization: Seoul National University Hospital

jintae73@gmail.com

82-2-2072-3661

Study Officials

• Jin-Tae Kim, MD. PhD.

  Seoul National University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: June 6, 2015
• First Posted: June 15, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)