An observational study to understand the efficacy of Ultrasound in confirming the correct placement of I-gel(an airway device)compared to Video-bronchoscopy.
- Conditions
- Malignant neoplasm of breast of unspecified site,
- Registration Number
- CTRI/2021/04/033223
- Lead Sponsor
- Dr Rajasree O
- Brief Summary
The devolopment of supraglottic airway devices[SAD] has revolutionised the airway management in anaesthesia practice.I-gel bieng a second generation SAD, bridges the niche between facemask and tracheal tube. The position of I-gel can be confirmed by various clinical methods inorder to avoid any airleaks and to ensure adequate ventilation.But one cannnot completely rely on clinical methods for confirming correct positioning of I-gel.Sub-optimal anatomical positioning with complete or partial obstruction of glottic aperture cannot ruled out by clinical methods alone.Clinical studies have shown that direct visualisation with Video-bronchoscopy can ensure correct placement of SAD, but its use is restricted due to its invasive nature and the need for thorough sterilisation and related expenses.
In these circumstances, the use of Ultrasound[US] have made correct positiong of I-gel, more reassuring.Hence we planned to compare the efficacy of Ultrasound[US] in confirming correct placement of I-gel with Video-bronchoscopy.
The primary objective of the study is to compare the USG images and Video-bronchoscopy images in detecting correct placement of I-gel. The secondary objective is to find the interrelationship between US detected and Video-bronchoscopy detected malposition of the I-gel and to determine the diagnostic capability of USG in detecting the I-gel malposition.
The expected outcome of the study is to detect the extend of malposition with USG aretynoid grade and Video-bronchoscopy I-gel rotation grade. Early detection of malposition can help in preventing intraoperative and postoperative complications by adjusting the position or replacing with I-gel of another size.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 153
Patients scheduled for breast sugeries under general anaesthesia,belonging to ASA physical status I and II,and those giving consent will be taken up for the study.
The following patients will be excluded; Patients with anticipated difficult airway,restrictive or obstructive pulmonary disease,previous thoracic surgeries,pregnancy,BMI >30,those at risk of gastric aspiration,and those who did not give consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare USG images and video-bronchoscopy images in detecting the correct placement of I-gel. 1 year
- Secondary Outcome Measures
Name Time Method To find the interrelationship between USG detected and video-bronchoscopy detected malposition of the I-gel and to determine the diagnostic capability of USG in detecting I-gel malposition. 1year
Trial Locations
- Locations (1)
Regional Cancer Centre Trivandrum
🇮🇳Thiruvananthapuram, KERALA, India
Regional Cancer Centre Trivandrum🇮🇳Thiruvananthapuram, KERALA, IndiaDr Rajasree OPrincipal investigator8281227024milisajan@hotmail.com