Comparison of Ventilation Tubes Among Anesthetized Pediatrics

June 3, 2020 updated by: Chien-Chung,Huang, Mackay Memorial Hospital

The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

June 5, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19MMHIS025e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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