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Comparison of Ventilation Tubes Among Anesthetized Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Institutional Review Board did not approve)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

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date June 5, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ventilation Tubes Among Anesthetized Pediatrics
Official Title  ICMJE The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Pulmonary Ventilation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    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
  • 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
    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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
100
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822689
Other Study ID Numbers  ICMJE 19MMHIS025e
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chien-Chung,Huang, Mackay Memorial Hospital
Study Sponsor  ICMJE Mackay Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chien-Chung Huang, MD Mackay Memorial Hospital
PRS Account Mackay Memorial Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP