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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLMA group | Experimental | In the FLMA group, a FLMA was applied. |
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| ETT group | Experimental | In the ETT group, guided by a visual laryngoscope, a ETT was intubated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airway Management: Flexible Reinforced Laryngeal Mask Airway | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Na Li, MD | Maternal and Child Health Hospital of Hubei Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternal and Child Health Hospital of Hubei Province | Wuhan | Hubei | 430000 | China |
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| Airway Management: Endotracheal Tube | Other | 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. |
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| 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 |
| 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 |
| 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 |