N/A N=39 Randomized Other

A Comparison of Different Ventilation Strategies in Infants Using the PLMA™

Ventilation

Bottom Line

View on ClinicalTrials.gov: NCT03235817 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2018

Primary outcome: Primary: Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. — 4.5; 7; 51.8; 49 cc/kg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Spontaneous ventilation (Other); Pressure support ventilation (Device); Pressure control ventilation (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Wake Forest University
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.	4.5; 7; 51.8; 49	—
PRIMARY Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups	51.8; 48.3; 4.5; 7.0	—
PRIMARY Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups	49.0; 48.3; 7.0; 7.0	—
SECONDARY Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.	32.2; 25.1	—
SECONDARY Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.	32.2; 22.3	—
SECONDARY Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.	25.1; 22.3	—

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 infants under general anesthesia. Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated (improved breathing) with the help of the breathing machine versus breathing on their own.

Eligibility Criteria

Inclusion Criteria

ASA (American Society of Anesthesiologists) physical classification of 1 or 2
Outpatient surgical procedures
Surgical procedure anticipated to be < 90 minutes
Subject age of 1 - 11 months (inclusive)

Exclusion Criteria

Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
ASA physical classification of 3, 4 or E
Premature infants or infants < 44 weeks post-conceptual age
Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03235817). 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.