Air-Q in Totally Edentulous and Dentate Geriatric Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorDiskapi Yildirim Beyazit Education and Research Hospital
About this trial
In this study, we aim to investigate the clinical performance, efficacy, and associated complications of the Air-Q Intubating Laryngeal Airway in totally edentulous and dentate geriatric patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65-90 year-old patients
Edentulous and gentate patients
American Society of Anesthesiologist Physical Status classification I-III,
Undergoing an elective operation under general anesthesia in our hospital
Disqualifiers
Predicted difficult airway (Mallampati class 4, mouth opening < 3 cm, or thyromental distance < 6 cm)
Body mass index (BMI) > 40 kg/m2
Patients with a high risk of aspiration (e.g., history of gastrectomy, -gastroesophageal reflux disease, or hiatal hernia),
Unstable vital signs
Trial design
Design model
Parallel
Treatments tested in this trial
edentulous geriatric patients
Other interventionEdentulous geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.
dentate geriatric patients
Other interventionDentate geriatric patients will be inserted Air-Q Intubating Airway under general anesthesia.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: edentulous groupActive comparator 1 intervention
Group B: gentate groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Measurement of oropharyngeal leak pressure (OLP)
One minute after successful LMA placement and fixation, oropharyngeal leak pressure
Time frame
One minute after successful LMA placementSecondary outcomes
1
Air-Q insertion time
Successful Air-Q placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Time frame
3 minutes after induction of anesthesia2
ease of SGA placement
Successful SGA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.
Time frame
3 minutes after induction of anesthesia3
maneuvers required for successful ventilation
It will be recorded whether any further maneuvers are required: Gentle pushing or pulling of the LMA to adjust its depth, jaw-thrust maneuver, and flexion or extension of the head.
Time frame
3 minutes after induction of anesthesia4
fiberoptic view grading
The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible.
Time frame
3 minutes after induction of anesthesiaOther outcomes
1
Complications during Air-Q removal (emerge)
Complications during SP\_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 \< 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded.
Time frame
One minute after Air-Q removal2
Sore throat
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame
1 hour postoperatively3
Sore throat
The presence or absence of sore throat will be recorded at the 24th postoperative hour
Time frame
24 hours postoperatively4
dysphonia
The presence or absence of dysphonia will be recorded at the firsth postoperative hour
Time frame
1 hour postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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