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Comparison of Ventilation Tubes Among Anesthetized Pediatrics

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ClinicalTrials.gov Identifier: NCT03822689
Recruitment Status : Withdrawn (Institutional Review Board did not approve)
First Posted : January 30, 2019
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Chien-Chung,Huang, Mackay Memorial Hospital

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Pulmonary Ventilation 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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Gas flow:2L
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
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
Active Comparator: Gas flow:5L
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Tidal volume [ Time Frame: 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

  2. End tidal carbon dioxide [ Time Frame: 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 :
  1. Body temperate [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822689


Locations
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Taiwan
MacKay Memorial Hospital
Taipei, Taiwan, 104
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Study Director: Chien-Chung Huang, MD Mackay Memorial Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Chien-Chung,Huang, attending physician, department of anesthesiology, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03822689    
Other Study ID Numbers: 19MMHIS025e
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chien-Chung,Huang, Mackay Memorial Hospital:
pediatric
Ventilation breathing tube
End-Tidal Carbon Dioxide
 Heart rate
tidal volume
blood temperature