The comparison between supreme laryngeal mask airway and endotracheal tube with respect to adequacy of ventilation in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Adequacy of ventilation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Adequacy of ventilation
Time Frame: From insertion of airway device to end of anaesthesia.
i) Quality of glottic airway seal – Difference between Inspired tidal volume and
Time Frame: From insertion of airway device to end of anaesthesia.
Expired tidal volume
Time Frame: From insertion of airway device to end of anaesthesia.
ii) Oxygen saturation
Time Frame: From insertion of airway device to end of anaesthesia.
iii) EtCO2
Time Frame: From insertion of airway device to end of anaesthesia.
iv) Peak airway pressures
Time Frame: From insertion of airway device to end of anaesthesia.
Secondary Outcomes
- 2. Ease of Insertion(Time required for achieving effective airway and the number of attempts for securing)