N/A N=33 Randomized Other

A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway

Intraoperative Ventilation

Bottom Line

View on ClinicalTrials.gov: NCT00966433 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. — 55.2; 47 mmHg — p=.0051

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Spontaneous ventilation (Procedure); Pressure support Ventilation (Device); Pressure control ventilation (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.	55.2; 47	.0051 sig
PRIMARY Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.	4.0; 7.6	.0001 sig
PRIMARY Mean Values of ETCO2 in SV and PCV Groups	55.2; 43.1	—
PRIMARY Mean Tidal Volume Values Compared Between SV and PCV Groups	4.0; 7.6	—
PRIMARY Mean Values of ETCO2 Between the PSV and PCV Groups	47.0; 43.1	—
PRIMARY Mean Values of Tidal Volume Between the PSV and PCV Groups	7.6; 7.6	—
SECONDARY Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.	28.1; 14.2	.0001 sig
SECONDARY Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.	28.1; 21.2	—
SECONDARY Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.	14.2; 21.2	—

Summary

The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in children under general anesthesia.

Eligibility Criteria

Inclusion Criteria

ASA physical classification 1, 2 (Healthy or relatively healthy children)
Subjects scheduled for outpatient surgical procedures.
Surgical procedure anticipated to be < 90 minutes
Subject weight of ≤ 20 kg (44 lbs)
Subject age of 12 months to 5 years (inclusive)

Exclusion Criteria

Inpatient
ASA physical classification of 3, 4 or E (sick children)
Risk of aspiration
Subjects with malignant hyperthermia or family history of malignant hyperthermia
Subjects with tracheostomies

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Data sourced from ClinicalTrials.gov (NCT00966433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.