Comparison of Ventilation Tubes Among Anesthetized Pediatrics

Pulmonary Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03822689
• Other study ID #: 19MMHIS025e
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2020
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Ventilation

Intervention

Device:
• 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

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-75. doi: 10.1213/ANE.0000000000000472. Review. — View Citation

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. — View Citation

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. Review. — View Citation

von Goedecke A, Brimacombe J, Hörmann C, Jeske HC, 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):357-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Body temperate	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