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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06356298
Other study ID # MCHH_004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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