Study Stopped
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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
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJune 5, 2020
June 1, 2020
1 year
January 25, 2019
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tidal volume
compared tidal volume besides different ventilation breathing tube
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
End tidal carbon dioxide
compared End tidal carbon dioxide besides different ventilation breathing tube
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
Secondary Outcomes (1)
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
Study Arms (2)
Gas flow:2L
ACTIVE COMPARATORuse 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
ACTIVE COMPARATORuse 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
Eligibility Criteria
You may qualify if:
- with American Society of Anesthesiologists (ASA) physical status classification 1\&2
- undergo elective surgery
- intubation
You may not qualify if:
- Cardiac-pulmonary surgery
- Had respiratory related disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MacKay Memorial Hospital
Taipei, 104, Taiwan
Related Publications (4)
Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.
PMID: 25625261BACKGROUNDKneyber MC. Intraoperative mechanical ventilation for the pediatric patient. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):371-9. doi: 10.1016/j.bpa.2015.10.001. Epub 2015 Oct 14.
PMID: 26643101BACKGROUNDGlenski TA, Diehl C, Clopton RG, Friesen RH. Breathing circuit compliance and accuracy of displayed tidal volume during pressure-controlled ventilation of infants: A quality improvement project. Paediatr Anaesth. 2017 Sep;27(9):935-941. doi: 10.1111/pan.13164. Epub 2017 May 15.
PMID: 28504341BACKGROUNDvon Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.
PMID: 15673856BACKGROUND
Study Officials
- STUDY DIRECTOR
Chien-Chung Huang, MD
Mackay Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attending physician, department of anesthesiology
Study Record Dates
First Submitted
January 25, 2019
First Posted
January 30, 2019
Study Start
October 1, 2020
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
June 5, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share