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COMPARATIVE STUDY BETWEEN LUNG PROTECTIVE AND CONVENTIONAL VENTILATION UNDERGOING CRANIOTOMY UNDER GENERAL ANAESTHESIA TO STUDY POSTOPERATIVE PULMONARY COMPLICATIONS.

COMPARATIVE STUDY BETWEEN LUNG PROTECTIVE AND CONVENTIONAL VENTILATION UNDERGOING CRANIOTOMY UNDER GENERAL ANAESTHESIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031326
Enrollment
160
Registered
2021-02-16
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: G89-G99- Other disorders of the nervous system Health Condition 2: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: LUNG PROTECTIVE VENTILATION: LUNG PROTECTIVE VENTILATION WITH TIDAL VOLUME OF 6ML/KG AND PEEP OF 8 CM H20. Control Intervention1: CONVENTIONAL VENTILATION: TIDAL VOLUME OF 10 ML/KG AND

Sponsors

VARDHAMAN AND MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults with American Society of Anaesthesiologist (ASA) physical status 1 and 2 undergoing elective neurosurgery with craniotomy in supine position, age between 18yrs-70yrs , Glasgow coma scale(GCS) >=8, Duration of surgery > 2 hours

Exclusion criteria

Exclusion criteria: Patients with history of chronic lung disease and pulmonary infection, past history of pulmonary surgery or received mechanical ventilation in past 2 weeks, heart disease, pregnant women, sepsis or septic shock, Body mass index (BMI) >35 kg/m2, patients requiring postoperative ventilation for >48hrs.

Design outcomes

Primary

MeasureTime frame
To compare the incidence of postoperative pulmonary complications with the use of lung protective and conventional ventilation in adult patients undergoing craniotomy under general anaesthesiaTimepoint: 24 HOURS AND TILL THE PATIENT IS SYMPTOMATIC FOR 1 WEEK OR DISCHARGE OR DEATH WHICHEVER IS EARLIER

Secondary

MeasureTime frame
1) To compare intraoperative and postoperative arterial blood gas analysis, PaO2/FiO2 2) To compare Intraoperative ventilator parameters( dynamic lung compliance, respiratory index, oxygen index, driving pressure) 3) To compare brain relaxation in the two groups. 4) To compare intraoperative and postoperative hemodynamic parameters.Timepoint: At baseline and every 5 minutes interval till half an hour after intubation followed by 30 min interval till the end of surgery and also at the below time intervals: T1- before changing the ventilator setting and after hemodynamic stabilization after intubation T2- 1h after changing the ventilator strategy T3- at the end of surgery T4- immediately after extubation

Countries

India

Contacts

Public ContactDR RANJU GANDHI

VARDHAMAN AND MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL

trisha27dec@gmail.com7004878381

Outcome results

None listed

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