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Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.
Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMA Supreme group | Active Comparator | Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia) |
|
| I-gel group | Active Comparator | Patient in I-gel group group received device of I-gel for airway management (one of supraglottic airway device for airway management during general anesthesia) |
|
| GMA-Tulip group | Experimental | Patient in GMA-Tulip group group received device of GMA-Tulip for airway management (one of supraglottic airway device for airway management during general anesthesia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA supreme group | Device | Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glottic exposure grading | Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed. | From the insertion of supraglottic airway device to the end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak inspiratory pressures | Record peak airway pressure during surgery. | From the insertion of supraglottic airway device to 15 minutes after insertion. |
| Plateau inspiratory pressures | Record plateau airway pressure during surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiangling Wang, Ph. D | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D056151 | Airway Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants, investigators, outcome assessor and statistician were blind to the study.
| I-gel group | Device | Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia |
|
| GMA-Tulip | Device | Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia |
|
| From the insertion of supraglottic airway device to 15 minutes after insertion. |
| Oropharyngeal leak pressure | Measure the oropharyngeal leak pressure after insertion of supraglottic airway device | From the insertion of supraglottic airway device to 30 minutes after insertion |
| Oropharyngeal leak pressure at 30 and 45 degrees of head rotation | Measure the oropharyngeal leak pressure at 30 and 45 degrees of head rotation after insertion of supraglottic airway device | From the insertion of supraglottic airway device to 30 minutes after insertion |
| Ventilation quality | Record the ventilation quality after the insertion of supraglottic airway device. In specific, The Ventilation Quality Score consists of three components: presence of normal CO₂ waveform, bilateral symmetrical chest rise, and absence of air leak at 20 mmHg airway pressure. Total scores range 0-3, with 0 indicating poor ventilation quality and 3 representing optimal ventilation. | From the insertion of supraglottic airway device to 15 minutes after insertion |
| Abnormally ventilation events during surgery | Record the abnormally ventilation events (air leakage, abnormal carbon dioxide wave, higher airway pressure, hypoxemia, supraglottic airway device adjustment, change into intubation) during surgery | From the insertion of supraglottic airway device to the end of surgery |
| Side effects at the end of surgery | Record side effects (blooding on the supraglottic airway device, pharyngalgia, hoarseness) at the end of surgery. | From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours. |
| Side effects and adverse events 24 hours after surgery | Record side effects (pharyngalgia, hoarseness, cough when drinking), and adverse events (pneumonia, hypoxemia) 24 hours after surgery. | Postoperative day 1. |
| Nasogastric tube insertion success rate | Record the nasogastric tube insertion success rate | From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes. |
| Nasogastric tube insertion attempts | Record the number of attempts for nasogastric tube insertion | From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes. |
| Nasogastric tube insertion time | Record the duration (seconds from insertion initiation to successful placement) of nasogastric tube insertion | From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes. |
| Nasogastric tube insertion difficulty | Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of nasogastric tube placement | From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes. |
| Reflux or aspiration risk | Record gas/fluid volume during the surgery | From the insertion of s SAD to the end of surgery. An average of 3 hours. |
| Supraglottic airway device insertion duration | Record the insertion duration (seconds from insertion initiation to successful placement) of SADs | From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds. |
| Supraglottic airway device insertion difficult | Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of SADs | From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds. |
| Supraglottic airway device insertion times | Record the number of SAD insertion attempts. | From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds. |