A Clinical Study to find which airway can be placed easily in patients under anaesthesia.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/10/028336
• Lead Sponsor: SRM medical College Hospital

Brief Summary

·         After obtaining institutional ethical committee approval, 66 patients between 18 to 60 years of age, posted for surgeries under general anaesthesia, will be recruited.

·         Informed consent, written in their own language will be obtained from all the patients.

·         Patients will be allocated to two groups (AMBU Auragain-AA group /LMA Protector- LP group) by computer generated random assignment prior to the start of the study. Patients  will be unaware of the group allocation.

·         After ensuring that patients are adequately fasted they will be premedicated with injection midazolam 0.03mg/kg IV and patients will be preloaded with 5 mL/kg of Ringer lactate solution through 18 gauge intravenous (IV) cannula half an hour prior to the procedure.

·         Monitors such as electrocardiography, pulse oximetry (SpO2) and non invasive blood pressure (NIBP) will be connected to the patient, baseline values will be documented and intraop hemodynamics will be monitored every 10 minutes.

·         Induction of anaesthesia will be done with fentanyl 2 μg/kg i.v. and propofol 2–2.5 mg/kg i.v. and maintenance with 50% oxygen and 50% air with 1 minimum alveolar concentration of sevoflurane. Patients then will be ventilated with a face mask till adequate jaw relaxation was achieved.

·         Before inserting the device, the cuff will be inflated with maximum permissible air (as per manufacturer’s recommendation), and the cuff pressure (*ex vivo*) was measured with a cuff pressure monitor.

·         Appropriate sized SGAs will be fully deflated and lubricated with a water-soluble gel. After the adequate depth of anaesthesia and once the muscle relaxation is achieved the patient’s head will be placed in a “sniffing†position (neck flexion and head extension) and lma will be inserted.

·         After insertion, the device will be inflated with the maximum permissible volume of air, and the air entry will be checked on both sides of the chest. The *in vivo* cuff pressure will be measured.

·         The pharyngeal mucosal pressure will be calculated as: *P*= *P*in vivo �’ *P*ex vivo.

·         We will record the number of insertion attempts and the time needed for SGA placement, (measured from when the SGA will be picked up until the connection to the breathing circuit and the appearance of 1st square waveform in capnograph).

·         The the ease of insertion will be graded as

1 - easy

2 - satisfactory

3 - difficult (when deep rotation and jaw thrust or a second attempt is used for proper                    device insertion).

·          An effective airway will be judged by an absence of audible leak , normal thoracoabdominal movement and square wave capnograph trace. If there is a leak, the SGA will be repositioned. If leak persists after a total of three attempts, the patient will be intubated with an endotracheal cuffed tube and will be recorded as failed insertions.

·         The anatomical alignment of the device to the larynx will be viewed through FOB just above the ventilating orifice. A grading scale will be used to assess the grade of view as follows:

•      4= only vocal cords seen;

•      3 = vocal cords plus posterior epiglottis seen;

•      2 = vocal cords plus anterior epiglottis seen;

•      1 = vocal cords not seen, but function adequate;

•      0 = failure to function where vocal cords not seen fibre-optically.

·         Before commencement of the surgery, the cuff will be inflated with a manometer and cuff pressure was set to 60 cm of H2O. OLP will be measured by closing the expiratory valve of the breathing circuit and delivering a gas flow of 3 L/min until the seal pressure.

·          A lubricated 16 Fr gastric tube will be introduced via the drain tube of both the devices to aspirate gastric contents. Ease of insertion of gastric tube through the gastric channel will be noted on a 3-point scale of 1–3 (1 = passed easily, 2 = passed with difficulty, 3 = impossible to pass).

·         Once the surgery is completed, awake extubation will be done.

·         Post procedure for 45 minutes patients hemodynamics will be monitored and they will also be monitored for complications like mucosal injury, persistent cough, laryngospasm, dysphonia, sore throat.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-09-10
• Study Start: 2020-12-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 1.ASA grade I-II 2.Surgeries requiring general anaesthesia with duration less than 1 hour .
• 3.BMI <30 4.MPC I to III 5.Upper lip bite test possible 6.Inter incisor distance > 2.5 cm 7.Thyromental distance > 6cm 8.Full range of neck movement.

Exclusion Criteria

• 1Surgeries requiring prone or lateral position.
• 2High risk of regurgitation (non fasted,morbid obesity, pregnancy, GERD) 3Preoperative sore throat or any respiratory tract infection 4Airway pathology, facial abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the ease of insertion including the insertion time and number of attmepts.	from the start of insertion to appearance of square wave in capnography

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	till 45mins after the removal of supraglottic airway device
Success of gastric tube insertion	easy/difficult/impossible
Oropharyngeal Leak pressure (OLP)	From securing LMA till fall in peak pressure
Fibreoptic assessment of larynx	grading

Trial Locations

Locations (1)

SRM Medical College Hospital and Research Centre; 🇮🇳 Kancheepuram, TAMIL NADU, India

SRM Medical College Hospital and Research Centre

🇮🇳Kancheepuram, TAMIL NADU, India

Abhinaya Murugappan

Principal investigator

7299073639

abhinaya1306@gmail.com