N/A
Completed N=39
A Comparison of Different Ventilation Strategies in Infants Using the PLMA™
Ventilation
Source: ClinicalTrials.gov NCT03235817 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: 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
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.
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 | — |
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.
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. Informational only — not medical advice.