COMPARISON OF EFFECTIVENESS AND SAFETY BETWEEN ENDOTRACHEAL TUBE AND LARYNGEAL MASK AIRWAY-PROSEALTM IN PATIENTS UNDERGOING SURGERY IN PRONE POSITION
Completed
- Conditions
- ASA 1 - 3
- Registration Number
- CTRI/2018/05/014217
- Lead Sponsor
- SDM College of Medical Sciences and Hospital
- Brief Summary
This study is a prospective, randomized, observational study comparing the safety and efficacy of endotracheal tube and Laryngeal Mask Airway – ProsealTM during a period between December 2015 and October 2017 in 48 patients that will be conducted in India. The primary outcome measures will be to see the efficacy of PLMA in prone position. The secondary outcomes will be to see the safety of PLMA in prone position.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Undergoing surgery in prone position 3.
- ASA physical status 1 to 3.
Exclusion Criteria
- Anticipated difficult airway 2.
- BMI ≥ 30 3.
- Patients not consenting for the study 4.
- Pregnancy or breast feeding females 5.
- Patients with present history of sore throat or dysphagia.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of PLMA in prone position 0-supine | 1-prone | 2-30 minutes | 3-60 minutes 1.Leak pressure (cmH2O) 0-supine | 1-prone | 2-30 minutes | 3-60 minutes 2.Ventilatory characteristics assessed by Tidal volume (VT) (ml), Respiratory rate (RR) (cycles/min), Minute Volume (MV) (litres), Peak [Ppeak] and mean airway pressure [Pmean] (cmH2O), compliance (ml/cmH2O). 0-supine | 1-prone | 2-30 minutes | 3-60 minutes
- Secondary Outcome Measures
Name Time Method Safety of PLMA in prone position 1.Number of attempts at insertion
Trial Locations
- Locations (1)
SDM College of Medical Sciences and Hospital
🇮🇳Dharwad, KARNATAKA, India
SDM College of Medical Sciences and Hospital🇮🇳Dharwad, KARNATAKA, IndiaDr Kanmani T LPrincipal investigator9986537663kanmani15@gmail.com