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Clinical Trials/CTRI/2024/12/078063
CTRI/2024/12/078063Not yet recruitingNot Applicable

Effects of Intraoperative Driving pressure on postoperative pulmonary complications in patients undergoing Minimally Invasive Colorectal Oncological surgeries: A Prospective Observational Study

ACTREC, Tata Memorial Centre1 site in 1 country103 target enrollmentStarted: December 24, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
103
Locations
1
Primary Endpoint
To assess the effect of intraoperative driving pressures on incidence of postoperative

Study Overview

Brief Summary

The purpose of this study is to investigate the relationship between  intraoperative driving pressure and postoperative pulmonary complications. It is a prospective observational study to be conducted over a period of 1 year in operating room of ACTREC, Tata Memorial Centre. This study will include patients of age more than 18 years undergoing minimally invasive colorectal cancer surgeries for a duration of more than 2 hours. On admission for surgery we will assess the fitness of the patient and obtain a written informed consent. Patients fulfilling the inclusion criteria will be observed intraoperatively. We will record all the vital intraoperative parameters and the ventilator parameters including the driving pressure and follow up the patients in the postoperative period for 30 days or until discharge for occurrence of any pulmonary complications.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients above 18 years planned for minimally invasive colorectal surgeries under general anaesthesia.

Exclusion Criteria

  • Emergency surgeries and Redo surgeries
  • Day care surgeries
  • Surgeries lasting for less than 2 hours
  • Patients with respiratory infection in the previous month
  • Patients with preexisting lung disease, poor ECOG and poor effort tolerance
  • Refusal to participate in the trial
  • Pregnant patients
  • Laparoscopic/Robotic surgery converted to open surgery.

Outcomes

Primary Outcomes

To assess the effect of intraoperative driving pressures on incidence of postoperative

Time Frame: Data will be collected during the surgery and in the postoperative period

pulmonary complications with simplified clinical pulmonary infection score in patients

Time Frame: Data will be collected during the surgery and in the postoperative period

undergoing minimally invasive colorectal surgeries.

Time Frame: Data will be collected during the surgery and in the postoperative period

Secondary Outcomes

  • 1.To assess the effect of mechanical power 6 on the incidence of postoperative pulmonary complications in the patients undergoing minimally invasive colorectal surgeries(2.To assess the patient outcomes)

Investigators

Sponsor
ACTREC, Tata Memorial Centre
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Malini Joshi

Tata Memorial Centre

Study Sites (1)

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