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A comparison of leak volume and leak fraction between supraglottic airway device i-gel an endotracheal tube during lap-cholecystectomy under general anesthesia in PCV-VG mode.

A COMPARATIVE STUDY BETWEEN I-GEL SUPRAGLOTTIC AIRWAY DEVICE AND CUFFED ENDOTRACHEAL TUBE FOR PRESSURE-CONTROLLED VOLUME GUARANTEED VENTILATION IN THE PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/058152
Enrollment
90
Registered
2023-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: laparoscopic cholecystectomy under general anesthesia, on PCV-VG mode 45 patients (Group I) airway will be secured with I-Gel.: ventilation will be carried out by ge care station ,pcv-v

Sponsors

office of the principal of midnapore medical college and hospital west medinipur 721101
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade 1 & 2 Modified Mallampatti 1 & 2 BMI < 30 KG/M2

Exclusion criteria

Exclusion criteria: 1.Patient’s refusal to take part in the study. 2.Patients with anticipated difficult airway, reduced mouth opening/disease of oral cavity 3.Patients requiring more than three attempts at intubation or I-gel insertion. 4.Surgery lasting more than more than 2 hours. 5.Very anxious patients or those who are unable to communicate. 6.Severe systemic disorder involving any particular system (respiratory, CVS, renal etc.) or in combination. 7.Inadequate cervical mobility/cervical malformation. 8.full stomach/increased risk of aspiration (GERD, hiatus hernia, diabetes mellitus) 9.Pregnancy,

Design outcomes

Primary

MeasureTime frame
To compare the leak fraction and leak volume between I-gel and Endo Tracheal Tube at 15, 20 and 25 cm of H2O airway pressure.Timepoint: Leak volume and Leak fraction will be measured at the time of insertion then every 10 minute interval up to 30 minute.

Secondary

MeasureTime frame
To compare intra op ventilatory parameter eg- Spo2, EtCo2. To compare insertion /intubation time, number of attempt. To compare postoperative pharyngo laryngeal morbidity. To compare (MAP), HR before insertion, during insertion, and after insertion.Timepoint: Every 15 min till removal ofd of SAD or extubation.

Countries

India

Contacts

Public ContactDR DEBASISH BHAR

MIDNAPORE MEDICAL COLLEGE AND HOSPITAL

debasish77bhar@gmail.com8617753967

Outcome results

None listed

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