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Comparison of Ventilation Tubes Among Anesthetized Pediatrics

NCT ID: NCT03822689

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-12-01

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Pulmonary Ventilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ventilator breathing tube F2220

Intervention Type DEVICE

M: Folding D: 22mm; L: 2.0M

Ventilator breathing tube F2216

Intervention Type DEVICE

M: Folding; D: 22mm; L:1.6M

Ventilator breathing tube F1520

Intervention Type DEVICE

M: Folding; D: 15mm; L:2.0M

Ventilator breathing tube F1516

Intervention Type DEVICE

M: Folding; D: 15mm; L:1.6M

Ventilator breathing tube U1016

Intervention Type DEVICE

M: Unfolding; D: 10mm; L:1.6M

Ventilator breathing tube U1516

Intervention Type DEVICE

M: Unfolding; D: 15mm; L:1.6M

Ventilator breathing tube CA20

Intervention Type DEVICE

M: Co-axis; L:2.0M

Ventilator breathing tube CA16

Intervention Type DEVICE

M: Co-axis; L:1.6M

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

Group Type ACTIVE_COMPARATOR

Ventilator breathing tube F2220

Intervention Type DEVICE

M: Folding D: 22mm; L: 2.0M

Ventilator breathing tube F2216

Intervention Type DEVICE

M: Folding; D: 22mm; L:1.6M

Ventilator breathing tube F1520

Intervention Type DEVICE

M: Folding; D: 15mm; L:2.0M

Ventilator breathing tube F1516

Intervention Type DEVICE

M: Folding; D: 15mm; L:1.6M

Ventilator breathing tube U1016

Intervention Type DEVICE

M: Unfolding; D: 10mm; L:1.6M

Ventilator breathing tube U1516

Intervention Type DEVICE

M: Unfolding; D: 15mm; L:1.6M

Ventilator breathing tube CA20

Intervention Type DEVICE

M: Co-axis; L:2.0M

Ventilator breathing tube CA16

Intervention Type DEVICE

M: Co-axis; L:1.6M

Interventions

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Ventilator breathing tube F2220

M: Folding D: 22mm; L: 2.0M

Intervention Type DEVICE

Ventilator breathing tube F2216

M: Folding; D: 22mm; L:1.6M

Intervention Type DEVICE

Ventilator breathing tube F1520

M: Folding; D: 15mm; L:2.0M

Intervention Type DEVICE

Ventilator breathing tube F1516

M: Folding; D: 15mm; L:1.6M

Intervention Type DEVICE

Ventilator breathing tube U1016

M: Unfolding; D: 10mm; L:1.6M

Intervention Type DEVICE

Ventilator breathing tube U1516

M: Unfolding; D: 15mm; L:1.6M

Intervention Type DEVICE

Ventilator breathing tube CA20

M: Co-axis; L:2.0M

Intervention Type DEVICE

Ventilator breathing tube CA16

M: Co-axis; L:1.6M

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chien-Chung,Huang

attending physician, department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chien-Chung Huang, MD

Role: STUDY_DIRECTOR

Mackay Memorial Hospital

Locations

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MacKay Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.

Reference Type BACKGROUND
PMID: 25625261 (View on PubMed)

Kneyber 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.

Reference Type BACKGROUND
PMID: 26643101 (View on PubMed)

Glenski 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.

Reference Type BACKGROUND
PMID: 28504341 (View on PubMed)

von 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.

Reference Type BACKGROUND
PMID: 15673856 (View on PubMed)

Other Identifiers

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19MMHIS025e

Identifier Type: -

Identifier Source: org_study_id

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