Adenotonsillectomy, Airway, Anesthesia Intubation Complication, Children
Conditions
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.
Interventions
OTHERAirway 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.
OTHERAirway 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.
Sponsors
Maternal and Child Health Hospital of Hubei Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Extubation time | Postoperative 30 minutes | Time to extubate, defined as occurrence of regular respiration from the end of the procedure. |
| Dosage of anesthetic | Intraoperative period, 30 minutes - 1.5 hours | The total amount of sedative and analgesic drugs will be recorded. |
| 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) |
| Surgeon satisfaction | Postoperative 30 minutes | Record the satisfaction of the surgeon with the FLMA or ETT, defined as a score out of100. |
| 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%), |
| 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. |
| 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) |
| 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. |
Countries
China
Outcome results
None listed