Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy

NCT06356298 | Completed Phase 2

• 1 other identifier: MCHH_004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy. Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia . The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.

Conditions

Anesthesia Intubation Complication; Airway; Adenotonsillectomy; Children

Outcome Measures

Primary Outcomes (3)

• Peak airway pressure

  Maximum peak airway pressure during surgery

  intraoperative period,10 minutes-1 hours

• Petco2

  Petco2 at the end of surgery

  intraoperative period,10 minutes-1 hour

• Ventilation leakage or not

  Using volume ventilation, tidal volume set to 10 ml /kg, Ventilation leakage is defined as reaching more than 20% of the set tidal volume.

  intraoperative period,10 minutes-1 hour

Secondary Outcomes (8)

• Mean arterial pressure (MAP)

  Intraoperative period, 30 minutes - 1.5 hours

• Heart rate (HR)

  Intraoperative period, 30 min - 1.5 hours

• Recovery time

  Postoperative 30 minutes

• Extubation time

  Postoperative 30 minutes

• Dosage of anesthetic

  Intraoperative period, 30 minutes - 1.5 hours

Study Arms (2)

FLMA group

EXPERIMENTAL

In the FLMA group, a FLMA was applied.

Other: Airway Management: Flexible Reinforced Laryngeal Mask Airway

ETT group

EXPERIMENTAL

In the ETT group, guided by a visual laryngoscope, a ETT was intubated.

Other: Airway Management: Endotracheal Tube

Interventions

Airway Management: Flexible Reinforced Laryngeal Mask Airway OTHER

In the FLMA group, a FLMA was applied according to the manufacturer's recommendations. After lubrication of the posterior surface with oxybuprocaine hydrochloride gel, the FLMA was inserted after propping the shoulders. Its cuff was fully deflated before insertion, and the pressure was adjusted to 40 cm H2O with a manometer after insertion.

FLMA group

Airway Management: Endotracheal Tube OTHER

In the ETT group, guided by a visual laryngoscope, a ETT was intubated after lubrication of the surface with oxybuprocaine hydrochloride gel: endotracheal tube size = (16+ age) /4. The cuff pressure of ETT was adjusted to 20 cm H2O with a handheld manometer after inflation.

ETT group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients who choose to have adenotonsillectomy surgery
• the American Society of Anesthesiologists (ASA) physical status ranked I-II
• the oropharyngeal anatomy is normal
• competent to provide informed consent

You may not qualify if:

• upper respiratory tract infection one week before surgery
• oropharyngeal anatomy is abnormal
• high risk of reflux aspiration
• liver or kidney failure
• psychiatric disorders

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Location

Study Officials

• Na Li, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: August 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CN (1)