To evaluate the working performance of two supraglottic airway devices - I-gel and Air-Q among patients posted for elective surgeries undergoing general anesthesia in general surgery and gynecology operation theater

“Evaluation of the working performance of two supraglottic airway devices - I-gel and air-Q among the patients posted for elective surgeries under General Anesthesia: Single blind Randomized control study”

Interventions: Air-Q will be compared to I-gel for securing the airway.

Aim : To evaluate the working performance of two supraglottic airway devices - I-gel and Air-Q  among patients posted for elective surgeries undergoing general anesthesia.

WHY THIS STUDY IS ESSENTIAL

Laryngoscopy and endotracheal intubation produce reflex sympathetic stimulation and causes tachycardia, hypertension,  and hemodynamic instability. (2)

Supraglottic airway devices(SGA) does not require Laryngoscopy and thus, it improves hemodynamic stability, no airway manipulation related complication, reduced intra operative anesthesia requirement and has less post operative complications compared to conventional intubation technique. (1,2)

This study will provide information about which supraglottic airway device - I-gel and Air-Q which is better in terms of insertion success and working performance. It will generate evidence about which one to prefer. Since both the devices can be used in same set of patients, it will guide to know which one between the two is good for the patient.

Objectives

Primary Objectives: to assess following parameters in both the groups

1. working performance in terms of oropharyngeal leak pressure, EtCO2 and Mean tidal expiration volume

2. insertion characteristics in terms of insertion time , number of attempts, manipulations required during insertion and

failed insertion ,if any.

Secondary Objectives: To assess the following parameters in both the groups

1. Ease of insertion of orogastric tube through SGA devices.

2. Perioperative hemodynamic response of the patient in terms of  pulse rate and mean atrial pressure.

3. Side effects and Complications if any (blood stained device, sore throat and laryngo-bronchospasm)

• Study design: Single blind Randomized control study

•Study population: Patients of either gender undergoing elective surgeries under general anesthesia

•Study setting: General surgery and Gynecology operation theater, Govt. Medical College , Bhavnagar

•Study Duration: 15months

•Time period for data collection: 12months

•Sample size: 88 (44 in each group)

•Sampling method – Simple random sampling

Inclusion criteria

1. Patients age 18 to 60 years

2. ASA (American society of anesthesiologist’s) grade I , II, III

3. Scheduled for elective surgery under general anesthesia

4. BMI<30kg/m2

Exclusion criteria

1. Patients with difficult airway and Mallampati Grade III and IV

2. Patients with history of supraglottic growth

3. Duration of surgery longer than 2 hours

                4) Patients with known case of  respiratory illness (like COPD , asthma, bronchitis etc.

LIST OF VARIABLES

•Independent variables: Age, Gender, Comorbidities, Type of SGA

•Dependent variables: Ease of insertion, timing of insertion, Oropharyngeal leak pressure, ease of inserting orogastric tube

•Confounding factors: Overweight (BMI 25-30kg/m2) , neck mobility, neck circumference, thyro-mental distance

METHODOLOGY

After approval from ethics committee and CTRI registration, All the patients who will be eligible in inclusion criteria will be included in this study.

Preanesthetic checkup of the patient and written informed consent of the patient will be taken in local language.

Patients will be randomized using computer generated random number sequence method into either group A or group I. Airway will be secured with Air-q and I-gel in group A and I respectively.