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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03931902

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted September 19, 2019

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.

  • Condition or Disease:Preterm Infant
    Anesthesia
    Respiratory Complication
  • Intervention/Treatment: Device: intubation with Endotracheal tube
    Device: intubation with laryngeal mask airway
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: The Comparison of Laryngeal Mask Airway and Endotracheal Tube in Premature Neonates Undergoing General Anesthesia for Inguinal Hernia Repair Surgery
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Active Comparator: Endotracheal Tube (ETT)
Using endotracheal tube as the airway device during general anesthesia
Device: intubation with Endotracheal tube
After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with endotracheal tube (ETT).
Experimental: Laryngeal Mask Airway (LMA)
Using laryngeal mask airway as the airway device during general anesthesia
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).
Outcome Measures
  • Primary Outcome Measures: 1. Perioperative respiratory complication [ Time Frame: from induction of anesthesia to postoperative 24 hours ]
    laryngospasm, bronchospasm, severe cough, delayed extubation or prolonged oxygen dependence, apnea, bradycardia, and postoperative stridor
  • 2. postoperative hospital stays [ Time Frame: from postoperative day 1 up to postoperative day 30 ]
    the lengths of postoperative hospital stays
Eligibility Criteria
  • Ages Eligible for Study: up to 52 / (18 to 64 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- preterm neonates (gestational age 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

Contacts and Locations
Contacts

Contact: Miao-Pei Su, Master 0088673121101 ext 7033 miaopeisu@gmail.com

Contact: Kuang-I Cheng, Master 0088673121101 ext 7033 cavia0803@gmail.com

Locations

Taiwan
Kaohsiung Medical University Hospital
Kaohsiung

Sponsors and Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Principal Investigator: Miaopei Su, Master Kaohsiung Medical University

More Information
  • Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
  • ClinicalTrials.gov Identifier: NCT03931902 History of Changes
  • Other Study ID Numbers: KMUHIRB-F(II)-20190017
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: September 19, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital: pediatric airway management
  • Additional relevant MeSH terms: Premature Birth