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出境医 / 临床实验 / The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates

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

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 Intervention/treatment Phase
Preterm Infant Anesthesia Respiratory Complication Device: intubation with Endotracheal tube Device: intubation with laryngeal mask airway Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 12, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
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).
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).
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
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Ages Eligible for Study:   up to 52 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Miao-Pei Su, Master 0088673121101 ext 7033 miaopeisu@gmail.com
Contact: Kuang-I Cheng, Master 0088673121101 ext 7033 cavia0803@gmail.com

Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Miao-Pei Su, Master    0088673121101 ext 7033    miaopeisu@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Miaopei Su, Master Kaohsiung Medical University
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE September 12, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2019)
  • 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
  • postoperative hospital stays [ Time Frame: from postoperative day 1 up to postoperative day 30 ]
    the lengths of postoperative hospital stays
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparison of Laryngeal Mask Airway and Endotracheal Tube in General Anesthesia for Premature Neonates
Official Title  ICMJE The Comparison of Laryngeal Mask Airway and Endotracheal Tube in Premature Neonates Undergoing General Anesthesia for Inguinal Hernia Repair Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Preterm Infant
  • Anesthesia
  • Respiratory Complication
Intervention  ICMJE
  • Device: intubation with Endotracheal tube
    After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with endotracheal tube (ETT).
  • 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).
Study Arms  ICMJE
  • Experimental: Laryngeal Mask Airway (LMA)
    Using laryngeal mask airway as the airway device during general anesthesia
    Intervention: Device: intubation with laryngeal mask airway
  • Active Comparator: Endotracheal Tube (ETT)
    Using endotracheal tube as the airway device during general anesthesia
    Intervention: Device: intubation with Endotracheal tube
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 27, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 52 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Miao-Pei Su, Master 0088673121101 ext 7033 miaopeisu@gmail.com
Contact: Kuang-I Cheng, Master 0088673121101 ext 7033 cavia0803@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931902
Other Study ID Numbers  ICMJE KMUHIRB-F(II)-20190017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Sponsor  ICMJE Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miaopei Su, Master Kaohsiung Medical University
PRS Account Kaohsiung Medical University Chung-Ho Memorial Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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