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Personalising the ventilator settings to the patient by a simple measure of pressure in their foodpipe(esophagus) during a surgery

Effect of Transpulmonary Pressure guided PEEP titration on post-operative oxygenation parameters compared to conventional PEEP application in patients undergoing Laparoscopic Pelvic surgery: An Open Label Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020556
Enrollment
90
Registered
2019-08-05
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: K00-K95- Diseases of the digestive system Health Condition 2: N00-N99- Diseases of the genitourinary system

Interventions

Intervention1: Titrating the PEEP according to Transpulmonary pressure: While still in the supine position esophgeal balloon catheter (MBMED Fluxmed GrT) will be inserted and its position will be conf

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: - American society of Anaesthesiologists physical status I and II - Scheduled for laparoscopic pelvic surgery

Exclusion criteria

Exclusion criteria: - Refusal to participate - Coexisting pulmonary, cardiovascular or oesophageal pathology - Previous oesophageal or pulmonary operation - Patient BMI less than 18 or BMI more than 30

Design outcomes

Primary

MeasureTime frame
To compare the effect of TPP guided PEEP application and conventional PEEP application (at 5cm H2O) on postoperative oxygenation parameters (PaO2/FiO2 ratio, A-aDO2, and SpO2)Timepoint: Baseline, 15 min post pneumo peritoneum, 15 min post Trendelenburg position, 30 min post shifting to Post-op area

Secondary

MeasureTime frame
To compare the effect of TPP guided PEEP application on intra-operative hemodynamic parameters of the patient [Mean Blood Pressure (MAP), Heart Rate (HR) and Pulse Pressure (PP)]Timepoint: Baseline, 15 min post pneumo peritoneum, 15 min post Trendelenburg position, 30 min post shifting to Post-op area;To compare the effect of TPP guided PEEP application on intra-operative respiratory mechanical parameters [Lung compliance (CL), Respiratory system Compliance (CRS), Chest wall Compliance (CCW), Lung Elastance (EL), Respiratory system Elastance (ERS), Chest wall Elastance (ECW), Plateau Pressure (PPLAT) and Peak Pressure (PPEAK)]Timepoint: Baseline, 15 min post pneumo peritoneum, 15 min post Trendelenburg position, 30 min post shifting to Post-op area

Countries

India

Contacts

Public ContactDr Samarth Agarwal

All India Institute of Medical Sciences, Jodhpur

samarthx@gmail.com8932938707

Outcome results

None listed

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