Clinical trial NCT03822689: Comparison of Ventilation Tubes Among Anesthetized Pediatrics
Official title: The Influences of Different Type of Ventilation Breathing Tube Among Children and Neonate Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Ventilation
Keywords: pediatric
Ventilation breathing tube
End-Tidal Carbon Dioxide
Heart rate
tidal volume
blood temperature
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Tidal volume
timeFrame: 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
measure: End tidal carbon dioxide
timeFrame: 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:
measure: Body temperate
timeFrame: 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
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Chien-Chung Huang, MD
role: STUDY_DIRECTOR
References:
citation: Feldman JM. Optimal ventilation of the anesthetized pediatric patient. Anesth Analg. 2015 Jan;120(1):165-175. doi: 10.1213/ANE.0000000000000472.
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.
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.
citation: 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.