The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates

NCT03931902 | Completed

• 1 other identifier: KMUHIRB-F(II)-20190017
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Anesthesia; Respiratory Complication

Keywords

pediatric airway management

Outcome Measures

Primary Outcomes (2)

• Perioperative respiratory complication

  laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor

  from induction of anesthesia to postoperative 24 hours

• postoperative hospital stays

  the lengths of postoperative hospital stays

  from postoperative day 1 up to postoperative day 30

Study Arms (2)

Laryngeal Mask Airway (LMA)

EXPERIMENTAL

Using laryngeal mask airway as the airway device during general anesthesia

Device: intubation with laryngeal mask airway

Endotracheal Tube (ETT)

ACTIVE COMPARATOR

Using endotracheal tube as the airway device during general anesthesia

Device: intubation with Endotracheal tube

Interventions

intubation with Endotracheal tube DEVICE

After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with endotracheal tube (ETT).

Endotracheal Tube (ETT)

intubation with laryngeal mask airway DEVICE

After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with laryngeal mask airway (LMA).

Laryngeal Mask Airway (LMA)

Eligibility Criteria

• Age: Up to 52 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Intubation; Laryngeal Masks

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques; Intubation, Intratracheal; Airway Management; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Miaopei Su, Master

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 30, 2019
• Study Start: September 12, 2019
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: March 15, 2022

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)