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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Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03822689
Enrollment
0
Registered
2019-01-30
Start date
2020-10-01
Completion date
2021-12-01
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Ventilation

Keywords

pediatric, Ventilation breathing tube, End-Tidal Carbon Dioxide, Heart rate, tidal volume, blood temperature

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).

Interventions

DEVICEVentilator breathing tube F2220

M: Folding D: 22mm; L: 2.0M

DEVICEVentilator breathing tube F2216

M: Folding; D: 22mm; L:1.6M

DEVICEVentilator breathing tube F1520

M: Folding; D: 15mm; L:2.0M

DEVICEVentilator breathing tube F1516

M: Folding; D: 15mm; L:1.6M

DEVICEVentilator breathing tube U1016

M: Unfolding; D: 10mm; L:1.6M

DEVICEVentilator breathing tube U1516

M: Unfolding; D: 15mm; L:1.6M

DEVICEVentilator breathing tube CA20

M: Co-axis; L:2.0M

DEVICEVentilator breathing tube CA16

M: Co-axis; L:1.6M

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tidal volumeFrom: 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 beginningcompared tidal volume besides different ventilation breathing tube
End tidal carbon dioxideFrom: 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 beginningcompared End tidal carbon dioxide besides different ventilation breathing tube

Secondary

MeasureTime frameDescription
Body temperateFrom: 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 beginningcompared Body temperate about different gas flow(2L,5L)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026