Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06356298
• Other study ID #: MCHH_004
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Maternal and Child Health Hospital of Hubei Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenotonsillectomy
• Airway
• Anesthesia Intubation Complication
• Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Hubei Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak airway pressure	Maximum peak airway pressure during surgery	intraoperative period,10 minutes-1 hours
Primary	Petco2	Petco2 at the end of surgery	intraoperative period,10 minutes-1 hour
Primary	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	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
Secondary	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
Secondary	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
Secondary	Extubation time	Time to extubate, defined as occurrence of regular respiration from the end of the procedure.	Postoperative 30 minutes
Secondary	Dosage of anesthetic	The total amount of sedative and analgesic drugs will be recorded.	Intraoperative period, 30 minutes - 1.5 hours
Secondary	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
Secondary	Surgeon satisfaction	Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100.	Postoperative 30 minutes
Secondary	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