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

NCT03235817 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-03-18

Study results available
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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.

Conditions

  • Ventilation

Interventions

OTHER

Spontaneous ventilation

The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.

DEVICE

Pressure support ventilation

The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.

DEVICE

Pressure control ventilation

The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Thomas Templeton, M.D. · Wake Forest

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-07-31
Completion
2010-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03235817 on ClinicalTrials.gov