Comparison of Ventilation Tubes Among Anesthetized Pediatrics

Not Applicable

Withdrawn

• Conditions: Pulmonary Ventilation
• Interventions: 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

• Registration Number: NCT03822689
• Lead Sponsor: Mackay Memorial Hospital

Brief 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).

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05
• Study Start: 2020-10-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gas flow:2L	Ventilator breathing tube F2220	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
Gas flow:2L	Ventilator breathing tube U1016	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
Gas flow:5L	Ventilator breathing tube F2220	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
Gas flow:2L	Ventilator breathing tube F2216	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
Gas flow:2L	Ventilator breathing tube F1516	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
Gas flow:2L	Ventilator breathing tube U1516	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
Gas flow:2L	Ventilator breathing tube CA20	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
Gas flow:2L	Ventilator breathing tube F1520	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
Gas flow:5L	Ventilator breathing tube F2216	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
Gas flow:5L	Ventilator breathing tube F1516	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
Gas flow:5L	Ventilator breathing tube CA20	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
Gas flow:2L	Ventilator breathing tube CA16	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
Gas flow:5L	Ventilator breathing tube CA16	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
Gas flow:5L	Ventilator breathing tube F1520	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
Gas flow:5L	Ventilator breathing tube U1016	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
Gas flow:5L	Ventilator breathing tube U1516	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

Primary Outcome Measures

Name	Time	Method
Tidal volume	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	compared tidal volume besides different ventilation breathing tube
End tidal carbon dioxide	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	compared End tidal carbon dioxide besides different ventilation breathing tube

Secondary Outcome Measures

Name	Time	Method
Body temperate	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	compared Body temperate about different gas flow(2L,5L)

Trial Locations

Locations (1)

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan