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Comparison of Ventilation Tubes Among Anesthetized Pediatrics

M

Mackay Memorial Hospital

Status

Withdrawn

Conditions

Pulmonary Ventilation

Treatments

Device: Ventilator breathing tube CA20
Device: Ventilator breathing tube CA16
Device: Ventilator breathing tube F2216
Device: Ventilator breathing tube U1016
Device: Ventilator breathing tube F1516
Device: Ventilator breathing tube U1516
Device: Ventilator breathing tube F1520
Device: Ventilator breathing tube F2220

Study type

Interventional

Funder types

Other

Identifiers

NCT03822689
19MMHIS025e

Details and patient eligibility

About

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).

Full 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).

Sex

All

Ages

Under 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Gas flow:2L
Active Comparator group
Description:
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
Treatment:
Device: Ventilator breathing tube U1516
Device: Ventilator breathing tube U1016
Device: Ventilator breathing tube CA16
Device: Ventilator breathing tube F1516
Device: Ventilator breathing tube CA20
Device: Ventilator breathing tube F1520
Device: Ventilator breathing tube F2216
Device: Ventilator breathing tube F2220
Gas flow:5L
Active Comparator group
Description:
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
Treatment:
Device: Ventilator breathing tube U1516
Device: Ventilator breathing tube U1016
Device: Ventilator breathing tube CA16
Device: Ventilator breathing tube F1516
Device: Ventilator breathing tube CA20
Device: Ventilator breathing tube F1520
Device: Ventilator breathing tube F2216
Device: Ventilator breathing tube F2220

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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