Comparison of Ventilation Tubes Among Anesthetized Pediatrics

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia

Conditions
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Pulmonary Ventilation

Intervention / Treatment
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* Device: Ventilator breathing tube F2220
* Device: Ventilator breathing tube F2216
* Device: Ventilator breathing tube F1520
* Device: Ventilator breathing tube F1516
* Device: Ventilator breathing tube U1016
* Device: Ventilator breathing tube U1516
* Device: Ventilator breathing tube CA20
* Device: Ventilator breathing tube CA16


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: with American Society of Anesthesiologists (ASA) physical status classification 1&2 undergo elective surgery intubation Exclusion Criteria: Cardiac-pulmonary surgery Had respiratory related disease

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gas flow:2L<br>use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M | Device: Ventilator breathing tube F2220<br>* M: Folding D: 22mm; L: 2.0M<br>Device: Ventilator breathing tube F2216<br>* M: Folding; D: 22mm; L:1.6M<br>Device: Ventilator breathing tube F1520<br>* M: Folding; D: 15mm; L:2.0M<br>Device: Ventilator breathing tube F1516<br>* M: Folding; D: 15mm; L:1.6M<br>Device: Ventilator breathing tube U1016<br>* M: Unfolding; D: 10mm; L:1.6M<br>Device: Ventilator breathing tube U1516<br>* M: Unfolding; D: 15mm; L:1.6M<br>Device: Ventilator breathing tube CA20<br>* M: Co-axis; L:2.0M<br>Device: Ventilator breathing tube CA16<br>* M: Co-axis; L:1.6M<br>|
| Active Comparator: Gas flow:5L<br>use different type ventilator breathing tube as follow Ventilator breathing tube F2220-M: Folding; D: 22mm; L:2.0M Ventilator breathing tube F2216-M: Folding; D: 22mm; L:1.6M Ventilator breathing tube F1520-M: Folding; D: 15mm; L:2.0M Ventilator breathing tube F1516-M: Folding; D: 15mm; L:1.6M Ventilator breathing tube U1016-M: Unfolding; D: 10mm; L:1.6M Ventilator breathing tube U1516-M: Unfolding; D: 15mm; L:1.6M Ventilator breathing tube CA20-.M: Co-axis; L:2.0M Ventilator breathing tube CA16- M: Co-axis; L:1.6M | Device: Ventilator breathing tube F2220<br>* M: Folding D: 22mm; L: 2.0M<br>Device: Ventilator breathing tube F2216<br>* M: Folding; D: 22mm; L:1.6M<br>Device: Ventilator breathing tube F1520<br>* M: Folding; D: 15mm; L:2.0M<br>Device: Ventilator breathing tube F1516<br>* M: Folding; D: 15mm; L:1.6M<br>Device: Ventilator breathing tube U1016<br>* M: Unfolding; D: 10mm; L:1.6M<br>Device: Ventilator breathing tube U1516<br>* M: Unfolding; D: 15mm; L:1.6M<br>Device: Ventilator breathing tube CA20<br>* M: Co-axis; L:2.0M<br>Device: Ventilator breathing tube CA16<br>* M: Co-axis; L:1.6M<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tidal volume | compared tidal volume besides different ventilation breathing tube | From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning | 
| End tidal carbon dioxide | compared End tidal carbon dioxide besides different ventilation breathing tube | From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperate | compared Body temperate about different gas flow(2L,5L) | From: 1 minute after endotracheal intubation, and vital signs include heart rate, blood pressure, EtCO2 did not change over 30%. To: eight types of tubes have already tested, up to 30 minutes after beginning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, Ventilation breathing tube, End-Tidal Carbon Dioxide, Heart rate, tidal volume, blood temperature