Health TrialsbyHealthPanel

The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Surgeries With Lateral Position Under General Anesthesia

ConditionOropharyngeal Leak Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

To compare the efficacy and safety of traditional inflatable laryngeal mask, i-gel non-inflatable laryngeal mask and GMA-TULIP non-inflatable laryngeal mask in surgeries with lateral position under general anesthesia, so that providing evidence for the selection of laryngeal mask in surgeries with lateral position.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients received surgeries in lateral position with an estimated surgery duration of less than 3 hours under general anesthesia.

Ages between 18 to 80, and body mass index less than 28 kg/m².

American Society of Anesthesiologists (ASA) Grades I-III.

Patients are willing to participate and be able to understand and sign an informed consent form.

Disqualifiers

Individuals with an open bite of less than 2cm.

Individuals with a history of obvious regurgitation of gastric contents and risk factors for aspiration.

Patients with combined pharyngeal and laryngeal lesions.

Predicting difficult airway patients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GMA-TULIP Laryngeal Mask

    Device

    After the anesthesia induction, use the GMA-TULIP laryngeal mask as the airway ventilation device.

  • i-gel Laryngeal Mask

    Device

    After the anesthesia induction, use the i-gel laryngeal mask as an airway ventilation device.

  • BlockBuster Laryngeal Mask

    Device

    After the anesthesia induction is over, use the BlockBuster laryngeal mask as the airway ventilation device.

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: GMA-TULIP Laryngeal Mask Group（D1 Group）Experimental treatment 1 intervention
Group B: i-gel Laryngeal Mask Group（D2 Group）Active comparator 1 intervention
Group C: BlockBuster Laryngeal Mask Group（D3 Group）Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

oropharyngeal leak pressure

After the laryngeal mask is successful inserted, set the fresh gas flow to 3 L/min in manual mode, turn the APL valve to 30 cmH2O, then listen to the neck. When hearing the sound of air leakage, the peak airway pressure at this time is the oropharyngeal leak pressure.

Time frame
1 minute after the laryngeal mask is successful inserted, 5 and 30 minutes after the lateral position

Secondary outcomes

1

The rate of first-insertion success

The successful insertion is defined as oropharyngeal leak pressure higher than 20 cmH2O and grade 1-2 of the laryngeal view under the fibreoptic bronchoscopy (indicating the accuracy of laryngeal mask positioning).

Time frame
1 minute after the first-attempt insertion of the laryngeal mask
2

The rate of total-insertion success

The total successful insertion is defined as ventilation with the allocated laryngeal mask after anesthesia induction

Time frame
1 minute after the airway is successfully controlled.
3

Time of insertion

Insertion time was defined as the time from the opening of the mouth by the operator to the positively insert the laryngeal mask. The time of glottic examination, adjustment between two ventilation insertions, and ventilation was not measured as ventilation insertion time.

Time frame
1 minute after successful insertion of the laryngeal mask
4

Times of laryngeal mask adjustment before the successful insertion

The times of laryngeal mask adjustments before successful laryngeal mask insertion.

Time frame
1 minute after the airway is successfully controlled.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Affiliated Hospital of Chongqing Medical University

Lead sponsor

Source ClinicalTrials.gov
Apply now