Trials / Withdrawn
WithdrawnNCT03822689
Comparison of Ventilation Tubes Among Anesthetized Pediatrics
The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Mackay Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To discover whether different types of ventilation breathing tube influence ventilation effect of children/ neonate, the investigators analysis tidal volume, end tidal carbon dioxide, compliance among children and neonate under general anesthesia. The study compares eight ventilator breathing tube of different length, diameter, material of the ventilator breathing tube. Besides, the investigators also make an approach verify the change of body temperate under different gas flow(2L, and 5L).
Detailed description
In previous research, initial mechanical ventilator settings about children were as following: 1.tidal volume 6 to 10 ml/kg of ideal body weight; 2.delta pressures of respiratory pressure should be \<10 cmH2O in healthy patients; 3. respiratory pressures could be kept less than 28 to 30 cmH2O in patient with lung injury; 4. positive end-expiratory pressure was necessary, although the optimal level is unknown. However, few researches discussed about Influences of different types of ventilation breathing tube. The investigators want to clarify the character about length, diameter, and material of the ventilation breathing tube under the ventilation system in relation to tidal volume, end tidal carbon dioxide, compliance among children and neonate. During this study, the participants will be 100 children who were ASA class1, 2 and performed non-emergency, non-cardiac surgery, who will receive general anesthesia . The participants will divide into three groups according to different body weights (Group N: \<4.5kg; Group T: 4.5\~20kg; Group C: \>20kg), and would receipt total eight type of ventilator breathing tube test. Primary outcome will be the difference of tidal volume, end tidal carbon dioxide and compliance. Besides, secondary outcome will be the change of body temperate under different gas flow (2L, and 5L).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ventilator breathing tube F2220 | M: Folding D: 22mm; L: 2.0M |
| DEVICE | Ventilator breathing tube F2216 | M: Folding; D: 22mm; L:1.6M |
| DEVICE | Ventilator breathing tube F1520 | M: Folding; D: 15mm; L:2.0M |
| DEVICE | Ventilator breathing tube F1516 | M: Folding; D: 15mm; L:1.6M |
| DEVICE | Ventilator breathing tube U1016 | M: Unfolding; D: 10mm; L:1.6M |
| DEVICE | Ventilator breathing tube U1516 | M: Unfolding; D: 15mm; L:1.6M |
| DEVICE | Ventilator breathing tube CA20 | M: Co-axis; L:2.0M |
| DEVICE | Ventilator breathing tube CA16 | M: Co-axis; L:1.6M |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2021-10-01
- Completion
- 2021-12-01
- First posted
- 2019-01-30
- Last updated
- 2020-06-05
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03822689. Inclusion in this directory is not an endorsement.