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

Kaohsiung Medical University

Status: Completed

Conditions: Respiratory Complication; Preterm Infant; Anesthesia

Treatments: Device: intubation with Endotracheal tube; Device: intubation with laryngeal mask airway

Study type: Interventional

Funder types: Other

Identifiers

NCT03931902

KMUHIRB-F(II)-20190017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: Under 52 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Laryngeal Mask Airway (LMA)

Experimental group

Description:

Using laryngeal mask airway as the airway device during general anesthesia

Treatment:

Device: intubation with laryngeal mask airway

Endotracheal Tube (ETT)

Active Comparator group

Description:

Using endotracheal tube as the airway device during general anesthesia

Treatment:

Device: intubation with Endotracheal tube