Comparing two devices which help the patient breathe under general anaesthesia - the endotracheal tube and the supreme laryngeal mask airway, for patients undergoing gall bladder removal surgery laparoscopically.
- Conditions
- Patients with gall stones, for removal of the gall bladder, by laparoscopic surgery.
- Registration Number
- CTRI/2017/11/010452
- Lead Sponsor
- PD Hinduja National Hospital and Medical Research Centre
- Brief Summary
**Hypothesis**- Theventilation of patients is adequate with both Supreme Laryngeal Mask Airway (LMAS) and Endotracheal Tube (ETT) undergoinglaparoscopic cholecystectomy under general anesthesia. My question is whetherLMAS is better than or similar to ETT in the ventilation of the patient.
**Rationale-** Laparoscopic cholecystectomy is done under general anesthesia.Under general anesthesia the patient cannot breathe on his own, so we need toput in an airway device to mechanically ventilate his lungs.
Till date, the cuffed endotracheal tube was considered as the goldstandard for providing a safe seal in the larynx, especially for laparoscopicprocedures under general anesthesia. The disadvantages of tracheal intubation,which involves rigid laryngoscopy, are in terms of concomitant haemodynamicresponses and damage to the oropharyngeal structures at insertion.Postoperative sore throat is also a serious concern. This precludes the globalutility of the tracheal tube and requires a better alternative. Over a periodof time, new airway devices have been added to the anaesthesiologist’sarmamentarium.
Supreme laryngeal mask airway (LMAS) is a supraglottic device whichhas an advanced cuff to provide a better seal around the laryngeal opening and permits peak airway pressure more than 30 cm waterwithout leak. It has a drain tube parallel to theventilation tube which permits drainage of passively regurgitated gastric fluidaway from the airway and serves as a passage for gastric tube. The LMAS is single use, latex freeand is made of medical grade PVC. The firm, elliptical andanatomically shaped airway tube facilitates easy insertion, without placingfingers in the patient’s mouth or placing an introducer tool for insertion.
This study is therefore undertaken to see if LMAS provides betteror similar ventilation than ETT in healthy adult patients undergoinglaparoscopic cholecystectomy under general anesthesia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 132
Consecutive 132 American Society of Anesthesiologists (ASA) status I and II adults of either sex, aged 20-65 years and body weight 40-80 kg, scheduled for elective laparoscopic cholecystectomy, under general anaesthesia, who had given consent to participate was recruited.
Patients with anticipated difficult airway, Obesity (body mass index >30 kg/m2), Oropharyngeal pathology, Cardiopulmonary disease, Cervical spine fracture or instability, Increased risk of aspiration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adequacy of ventilation From insertion of airway device to end of anaesthesia. i) Quality of glottic airway seal – Difference between Inspired tidal volume and From insertion of airway device to end of anaesthesia. Expired tidal volume From insertion of airway device to end of anaesthesia. ii) Oxygen saturation From insertion of airway device to end of anaesthesia. iii) EtCO2 From insertion of airway device to end of anaesthesia. iv) Peak airway pressures From insertion of airway device to end of anaesthesia.
- Secondary Outcome Measures
Name Time Method 2. Ease of Insertion Time required for achieving effective airway and the number of attempts for securing
Trial Locations
- Locations (1)
P.D. Hinduja National Hospital and Medical Research Centre
🇮🇳Mumbai, MAHARASHTRA, India
P.D. Hinduja National Hospital and Medical Research Centre🇮🇳Mumbai, MAHARASHTRA, IndiaDeepak BhushanPrincipal investigator9821859729lion.deepak@gmail.com