N/A
Completed N=33
A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
Intraoperative Ventilation
Source: ClinicalTrials.gov NCT00966433 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. — 55.2; 47 mmHg — p=.0051
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.
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 | — |
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
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. Informational only — not medical advice.