Comparison of two supraglottic airway devices in patients undergoing surgery under general anaesthesia.

Comparative study of a third generation supraglottic airway device versus a second generation supraglottic airway device in adult patients undergoing elective surgery under general anaesthesia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024854

Enrollment

Registered

2020-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patients undergoing surgery under general anaesthesia

Interventions

Intervention1: Comparison of oropharyngeal seal pressure with baska mask in patients undergoing elective surgery under general anaesthesia: The Baska mask will be inserted after induction of anesthesi

Eligibility

Inclusion criteria

Inclusion criteria: a)Age group of 18 to 60 years, b)Weighing 30- 70 Kg , c)American society of Anaesthesiologists (ASA) physical status Iand II d)Undergoing elective surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: 1)Patients with anticipated difficult airway including: Thyromental distance less than 6.5 cm, Upper lip bite test class more than 1, Mallampatti class III and IV, Restricted head and neck mobility Mouth opening less than 3.5 cm BMI more than 30 kg/m 2 2) Cervical spine pathology 3) Intestinal and oesophageal pathology 4) Operation time greater than 4 hours 5) High risk of aspiration ( gastroesophageal reflux/treated disease) 6) Preoperative sore throat 7) Poor dentition with high risk of damage 8) Pregnancy 9) Patients undergoing laparoscopic surgery

Design outcomes

Primary

Measure	Time frame
To compare oropharyngeal leak pressure of Baska mask with that of LMA Proseal in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation.Timepoint: 5 minutes and 30 minutes	—

Secondary

Measure	Time frame
1. Number of attempts taken for successful insertion of device- 2. Time for achieving effective airway: 3.number of patients requiring manipulation for achieving effective airway and type of manipulation 4. Ease of insertion of device 5. Leak percent 6. Intraoperative ( aspiration, trauma, desaturation, laryngospasm,brochosapsm, airway obstruction) and postoperative adverse events( sorethroat, dysphagia and hoarseness) Timepoint: parameter 1-4 will be recorded immediately after insertion of device ( Time 0) leak percent will be done 5 min post device insertion adverse events will be recorded as follows sore throat (1 and 24 hours)	—

Measure

Time frame

1. Number of attempts taken for successful insertion of device- 2. Time for achieving effective airway: 3.number of patients requiring manipulation for achieving effective airway and type of manipulation 4. Ease of insertion of device 5. Leak percent 6. Intraoperative ( aspiration, trauma, desaturation, laryngospasm,brochosapsm, airway obstruction) and postoperative adverse events( sorethroat, dysphagia and hoarseness) Timepoint: parameter 1-4 will be recorded immediately after insertion of device ( Time 0) leak percent will be done 5 min post device insertion adverse events will be recorded as follows sore throat (1 and 24 hours)

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Countries

India

Contacts

Public ContactNidhi Agrawal

Vardhman Mahavir Medical College and Safdarjung Hospital

golu3191@gmail.com9811030408

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026