Back to resultsThe Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
Primary Purpose
Preterm Infant, Anesthesia, Respiratory Complication
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
intubation with Endotracheal tube
intubation with laryngeal mask airway
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infant focused on measuring pediatric airway management
Eligibility Criteria
Inclusion Criteria:
- preterm neonates (gestational age < 37 weeks) in our neonatal ward scheduled to receive unilateral or bilateral inguinal hernia repair surgery, and whose body weight > 2000g at surgery
Exclusion Criteria:
- emergent surgery, infants who was intubated before surgery, long-term oxygen or mechanical ventilation dependence, severe congenital cardiopulmonary disease, lacking of birth history, combination with other major surgery, postmenstrual age > 52 weeks at surgery
Sites / Locations
- Kaohsiung Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laryngeal Mask Airway (LMA)
Endotracheal Tube (ETT)
Arm Description
Using laryngeal mask airway as the airway device during general anesthesia
Using endotracheal tube as the airway device during general anesthesia
Outcomes
Primary Outcome Measures
Perioperative respiratory complication
laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor
postoperative hospital stays
the lengths of postoperative hospital stays
Secondary Outcome Measures
Full Information
NCT ID
NCT03931902
First Posted
April 23, 2019
Last Updated
March 13, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03931902
Brief Title
The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
Official Title
The Comparison of Laryngeal Mask Airway and Endotracheal Tube in Premature Neonates Undergoing General Anesthesia for Inguinal Hernia Repair Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives: To compare the perioperative respiratory adverse events between using laryngeal mask airway and endotracheal tube in preterm neonates receiving general anesthesia for hernia surgery.
Detailed Description
The participant patients will be randomly allocated into two groups: the laryngeal mask airway group (LMA group) and endotracheal tube group (ETT group). Masking ventilation with sevoflurane will be used for anesthesia induction till the adequate anesthetic depth. Intubation with laryngeal mask airway (LMA) or endotracheal tube (ETT) will be done as allocated group. After the surgery completed and the patient wakened up, the anesthesiologist will remove the LMA or ETT according to the clinical criteria for extubation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Anesthesia, Respiratory Complication
Keywords
pediatric airway management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laryngeal Mask Airway (LMA)
Arm Type
Experimental
Arm Description
Using laryngeal mask airway as the airway device during general anesthesia
Arm Title
Endotracheal Tube (ETT)
Arm Type
Active Comparator
Arm Description
Using endotracheal tube as the airway device during general anesthesia
Intervention Type
Device
Intervention Name(s)
intubation with Endotracheal tube
Intervention Description
After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with endotracheal tube (ETT).
Intervention Type
Device
Intervention Name(s)
intubation with laryngeal mask airway
Intervention Description
After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with laryngeal mask airway (LMA).
Primary Outcome Measure Information:
Title
Perioperative respiratory complication
Description
laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor
Time Frame
from induction of anesthesia to postoperative 24 hours
Title
postoperative hospital stays
Description
the lengths of postoperative hospital stays
Time Frame
from postoperative day 1 up to postoperative day 30
10. Eligibility
Sex
All
Maximum Age & Unit of Time
52 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
preterm neonates (gestational age < 37 weeks) in our neonatal ward scheduled to receive unilateral or bilateral inguinal hernia repair surgery, and whose body weight > 2000g at surgery
Exclusion Criteria:
emergent surgery, infants who was intubated before surgery, long-term oxygen or mechanical ventilation dependence, severe congenital cardiopulmonary disease, lacking of birth history, combination with other major surgery, postmenstrual age > 52 weeks at surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miaopei Su, Master
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
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