Two ventilatory device are being compared in this study for ventilation in laparoscopic surgery done for removal of gall bladder.

Comparison of clinical efficacy of laryngeal mask airway Protector with laryngeal mask airway Proseal for ventilation in patient undergoing laparoscopic cholecystectomy under general anaesthesia. - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057309

Enrollment

144

Registered

2023-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis

Interventions

Intervention1: nil: nil Control Intervention1: laryngeal mask airway: Laryngeal Mask Airway Protector is being compared with Laryngeal Mask Airway Proseal in term of oropharyngeal seal pressure and o

Eligibility

Inclusion criteria

Inclusion criteria: 144 patients, in age group of 18 to 60 years, American society of Anaesthesiologists (ASA) physical status I and II undergoing laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: Patients with anticipated difficult airway including: Thyromental distance Restricted head and neck mobility, Mouth opening 30kg/m2, Cervical spine pathology, High risk of aspiration.

Design outcomes

Primary

Measure	Time frame
Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.Timepoint: Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.	—

Measure

Time frame

Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.Timepoint: Oropharyngeal leak pressure will be noted within 5 minutes after device insertion. Other reading of oropharyngeal leak pressure will be taken after inflation & after deflation of carboperitoneum.

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Secondary

Measure	Time frame
insertion characteristics 1.NUMBER OF ATTEMPTS TAKEN FOR SUCCESSFUL INSERTION OF DEVICE 2.TIME FOR ACHIEVING EFFECTIVE VENTILATION 3.NUMBER OF PATIENTS REQUIRING MANIPULATION FOR ACHIEVING EFFECTIVE VENTILATION AND TYPE OF MANIPULATION 4.EASE OF INSERTION OF DEVICE 5. EASE OF GASTRIC CATHETER INSERTION 6. SCORE REGARDING ANATOMICAL ALIGNMENT OF DEVICE 7.LEAK PERCENT 8.INTRAOPERATIVE AND POSTOPERATIVE ADVERSE EVENTSTimepoint: 1.At time of insertion of device 2.Just after Insertion of Device 3.During Insertion 4.At time of insertion of device 5.During insertion of device. 6.Just after insertion 7.1 min after insertion, just before carboperitoneum, 5 mins after carboperitoneum, 5 mins after deflating carboperitoneum. 8.After completion of Surgery	—

Measure

Time frame

insertion characteristics 1.NUMBER OF ATTEMPTS TAKEN FOR SUCCESSFUL INSERTION OF DEVICE 2.TIME FOR ACHIEVING EFFECTIVE VENTILATION 3.NUMBER OF PATIENTS REQUIRING MANIPULATION FOR ACHIEVING EFFECTIVE VENTILATION AND TYPE OF MANIPULATION 4.EASE OF INSERTION OF DEVICE 5. EASE OF GASTRIC CATHETER INSERTION 6. SCORE REGARDING ANATOMICAL ALIGNMENT OF DEVICE 7.LEAK PERCENT 8.INTRAOPERATIVE AND POSTOPERATIVE ADVERSE EVENTSTimepoint: 1.At time of insertion of device 2.Just after Insertion of Device 3.During Insertion 4.At time of insertion of device 5.During insertion of device. 6.Just after insertion 7.1 min after insertion, just before carboperitoneum, 5 mins after carboperitoneum, 5 mins after deflating carboperitoneum. 8.After completion of Surgery

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Countries

India

Contacts

Public ContactNidhi Agrawal

Vardhman Mahavir medical college and Safdarjung hospital

nidhi.agrawal1970@gmail.com9811030408

Outcome results

None listed

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