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

Not Applicable

Completed

• Conditions: Respiratory Complication; Preterm Infant; Anesthesia
• Interventions: Device: intubation with Endotracheal tube; Device: intubation with laryngeal mask airway

• Registration Number: NCT03931902
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-27
• Study First Posted: 2019-04-30
• Study Start: 2019-09-12
• Status Verified: 2020-12
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-25
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal Tube (ETT)	intubation with Endotracheal tube	Using endotracheal tube as the airway device during general anesthesia
Laryngeal Mask Airway (LMA)	intubation with laryngeal mask airway	Using laryngeal mask airway as the airway device during general anesthesia

Primary Outcome Measures

Name	Time	Method
Perioperative respiratory complication	from induction of anesthesia to postoperative 24 hours	laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor
postoperative hospital stays	from postoperative day 1 up to postoperative day 30	the lengths of postoperative hospital stays

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan