Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy
- Conditions
- Anesthesia Intubation ComplicationChildrenAdenotonsillectomyAirway
- Registration Number
- NCT06356298
- Lead Sponsor
- Maternal and Child Health Hospital of Hubei Province
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Peak airway pressure intraoperative period,10 minutes-1 hours Maximum peak airway pressure during surgery
Petco2 intraoperative period,10 minutes-1 hour Petco2 at the end of surgery
Ventilation leakage or not intraoperative period,10 minutes-1 hour Using volume ventilation, tidal volume set to 10 ml /kg, Ventilation leakage is defined as reaching more than 20% of the set tidal volume.
- Secondary Outcome Measures
Name Time Method Mean arterial pressure (MAP) Intraoperative period, 30 minutes - 1.5 hours 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)
Heart rate (HR) Intraoperative period, 30 min - 1.5 hours 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)
Extubation time Postoperative 30 minutes Time to extubate, defined as occurrence of regular respiration from the end of the procedure.
Success of FLMA or ETT Intraoperative period, 10 minutes - 1hour The first success of FLMA or ETT rate will be recorded, and insertion over three times will be considered as failed intubation.
Surgeon satisfaction Postoperative 30 minutes Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100.
Recovery time Postoperative 30 minutes 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.
Dosage of anesthetic Intraoperative period, 30 minutes - 1.5 hours The total amount of sedative and analgesic drugs will be recorded.
Adverse events Postoperative 1 hour 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%),
Trial Locations
- Locations (1)
Maternal and Child Health Hospital of Hubei Province
🇨🇳Wuhan, Hubei, China