Clinical trial NCT06383494: GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management
Official title: GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Airway Remodeling
Keywords: Supraglottic airway device
Laryngeal inlet encapsulation
LMA-Supreme
i-gel
Fiberoptic alignment
Optimal anatomical position
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glottic exposure grading
timeFrame: From the insertion of supraglottic airway device to the end of surgery.
Secondary outcomes:
measure: Peak inspiratory pressures
timeFrame: From the insertion of supraglottic airway device to 15 minutes after insertion.
measure: Plateau inspiratory pressures
timeFrame: From the insertion of supraglottic airway device to 15 minutes after insertion.
measure: Oropharyngeal leak pressure
timeFrame: From the insertion of supraglottic airway device to 30 minutes after insertion
measure: Oropharyngeal leak pressure at 30 and 45 degrees of head rotation
timeFrame: From the insertion of supraglottic airway device to 30 minutes after insertion
measure: Ventilation quality
timeFrame: From the insertion of supraglottic airway device to 15 minutes after insertion
measure: Abnormally ventilation events during surgery
timeFrame: From the insertion of supraglottic airway device to the end of surgery
measure: Side effects at the end of surgery
timeFrame: From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours.
measure: Side effects and adverse events 24 hours after surgery
timeFrame: Postoperative day 1.
measure: Nasogastric tube insertion success rate
timeFrame: From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.
measure: Nasogastric tube insertion attempts
timeFrame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
measure: Nasogastric tube insertion time
timeFrame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
measure: Nasogastric tube insertion difficulty
timeFrame: From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.
measure: Reflux or aspiration risk
timeFrame: From the insertion of supraglottic airway device to the end of surgery. An average of 3 hours.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Jiangling Wang, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: