Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy

Airway Management Effects of Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy：a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Children; Adenotonsillectomy; Anesthesia Intubation Complication; Airway
• Intervention / Treatment: Other: Airway Management: Flexible Reinforced Laryngeal Mask Airway; Other: Airway Management: Endotracheal Tube

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Maternal and Child Health Hospital of Hubei Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLMA group; In the FLMA group, a FLMA was applied.	Other: Airway Management: Flexible Reinforced Laryngeal Mask Airway; 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.
Experimental: ETT group; In the ETT group, guided by a visual laryngoscope, a ETT was intubated.	Other: Airway Management: Endotracheal Tube; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Time to fully awake, defined as by a modified Aldrete score which will be recorded every 3 minutes from the end of the procedure with a recovery index (MAS) of 9 or more.	Postoperative 30 minutes
Mean arterial pressure (MAP)	MAP level will be monitored and recorded at 6 time points, including the entry into the operation room (Time 0), 2 min after anesthesia induction (Time 1), implantation of FLMA or ETT (Time 2), implantation of mouth opener (Time 3) ，at the end of surgery (Time 4), and after removal of FLMA or ETT (Time 5)	Intraoperative period, 30 minutes - 1.5 hours
Heart rate (HR)	HR will be monitored and recorded at 4 time points, including the entry into the operation room (Time 0), 2 min after anesthesia induction (Time 1), implantation of FLMA or ETT (Time 2), implantation of mouth opener (Time 3) ，at the end of surgery (Time 4), and after removal of FLMA or ETT (Time 5)	Intraoperative period, 30 min - 1.5 hours
Extubation time	Time to extubate, defined as occurrence of regular respiration from the end of the procedure.	Postoperative 30 minutes
Dosage of anesthetic	The total amount of sedative and analgesic drugs will be recorded.	Intraoperative period, 30 minutes - 1.5 hours
Success of FLMA or ETT	The first success of FLMA or ETT rate will be recorded, and insertion over three times will be considered as failed intubation.	Intraoperative period, 10 minutes - 1hour
Surgeon satisfaction	Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100.	Postoperative 30 minutes
Adverse events	The adverse events will be monitored and recorded during the operation and post-operation. AE will include: nausea and vomiting, reflux aspiration, hoarseness, dysphagia, sore throat, coughing, bronchospasm, laryngeal spasm, mask with blood, respiratory depression (defined as SpO2< 90%),	Postoperative 1 hour

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Investigators: Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MCHH_004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No