Airway Remodeling, Anesthesia
Conditions
Keywords
Supraglottic airway device, Laryngeal inlet encapsulation, LMA-Supreme, i-gel, Fiberoptic alignment, Optimal anatomical position
Brief summary
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.
Detailed description
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.
Interventions
DEVICELMA supreme group
Patient in this group received LMA supreme (one of laryngeal airway management device) for airway management during general anesthesia
DEVICEI-gel group
Patient in this group received I-gel laryngeal (one of laryngeal airway management device) for airway management during general anesthesia
DEVICEGMA-Tulip
Patient in this group received GMA-Tulip (one of laryngeal airway management device) for airway management during general anesthesia
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, investigators, outcome assessor and statistician were blind to the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years old; * American Society of Anesthesiologists (ASA) I-III; * Body mass index (BMI)\<30Kg/m2; * Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours; * Providing written inform consent.
Exclusion criteria
* History of oropharyngeal surgery and anatomical abnormalities; * Limited movement of the cervical spine; * High risk of reflux/aspiration; * Emergency surgery; * Acute throat inflammation and upper respiratory infection; * History of chronic bronchitis or asthma; * Cognitive dysfunction and inability to communicate; * Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glottic exposure grading | From the insertion of supraglottic airway device to the end of surgery. | Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plateau inspiratory pressures | From the insertion of supraglottic airway device to 15 minutes after insertion. | Record plateau airway pressure during surgery. |
| Oropharyngeal leak pressure | From the insertion of supraglottic airway device to 30 minutes after insertion | Measure the oropharyngeal leak pressure after insertion of supraglottic airway device |
| Oropharyngeal leak pressure at 30 and 45 degrees of head rotation | From the insertion of supraglottic airway device to 30 minutes after insertion | Measure the oropharyngeal leak pressure at 30 and 45 degrees of head rotation after insertion of supraglottic airway device |
| Ventilation quality | From the insertion of supraglottic airway device to 15 minutes after insertion | 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. |
| Abnormally ventilation events during surgery | From the insertion of supraglottic airway device to the end of 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 |
| Side effects 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. | Record side effects (blooding on the supraglottic airway device, pharyngalgia, hoarseness) at the end of surgery. |
| Side effects and adverse events 24 hours after surgery | Postoperative day 1. | Record side effects (pharyngalgia, hoarseness, cough when drinking), and adverse events (pneumonia, hypoxemia) 24 hours after surgery. |
| Peak inspiratory pressures | From the insertion of supraglottic airway device to 15 minutes after insertion. | Record peak airway pressure during surgery. |
| Nasogastric tube insertion attempts | From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes. | Record the number of attempts for nasogastric tube insertion |
| Nasogastric tube insertion time | From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes. | Record the duration (seconds from insertion initiation to successful placement) of nasogastric tube insertion |
| Nasogastric tube insertion difficulty | From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes. | Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of nasogastric tube placement |
| Reflux or aspiration risk | From the insertion of s SAD to the end of surgery. An average of 3 hours. | Record gas/fluid volume during the surgery |
| Supraglottic airway device insertion duration | From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds. | Record the insertion duration (seconds from insertion initiation to successful placement) of SADs |
| Supraglottic airway device insertion difficult | From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds. | Record the insertion difficulty (1-3 scale; 1=easy, 3=difficult) of SADs |
| Supraglottic airway device insertion times | From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds. | Record the number of SAD insertion attempts. |
| Nasogastric tube insertion success rate | From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes. | Record the nasogastric tube insertion success rate |
Countries
China
Outcome results
None listed