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

NCT ID: NCT03931902

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2021-05-25

Brief Summary

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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

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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.

Conditions

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Preterm Infant Anesthesia Respiratory Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laryngeal Mask Airway (LMA)

Using laryngeal mask airway as the airway device during general anesthesia

Group Type EXPERIMENTAL

intubation with laryngeal mask airway

Intervention Type DEVICE

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

Endotracheal Tube (ETT)

Using endotracheal tube as the airway device during general anesthesia

Group Type ACTIVE_COMPARATOR

intubation with Endotracheal tube

Intervention Type DEVICE

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

Interventions

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intubation with Endotracheal tube

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

Intervention Type DEVICE

intubation with laryngeal mask airway

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

52 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miaopei Su, Master

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUHIRB-F(II)-20190017

Identifier Type: -

Identifier Source: org_study_id

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