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Clinical Trials/CTRI/2021/09/036699
CTRI/2021/09/036699CompletedNot Applicable

The effect of two different intraoperative inspired oxygen concentration on postoperative pulmonary atelectasis in Geriatric patients undergoing elective surgery under general anesthesia: a Randomized-Controlled Trial

All India Institute of Medical Sciences AIIMS Jodhpur1 site in 1 country48 target enrollmentStarted: January 10, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
To compare the incidence and severity of postoperative atelectasis determined by CT thorax.

Study Overview

Brief Summary

All patients requiring general anaesthesia need oxygen administration. Supplementing patients with high inspired oxygen is considered to have harmful effects on lung physiology and increases the chances of postoperative pulmonary complications. But recent studies suggest that there is no clinically significant difference in postoperative lung atelectasis between low and high intraoperative inspired oxygen. However, high inspired oxygen is beneficial in reducing incidence of postoperative vomiting and surgical site infection. Most of the studies have been conducted in healthy individual to our best knowledge.

So,we planned to do a randomised study on the effect of two different intraoperative inspired oxygen concentrations on postoperative pulmonary atelectasis in geriatric patients undergoing elective surgeries.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Eligibility Criteria

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

Inclusion Criteria

  • •Patients aged more than 60 years and scheduled for elective major surgery of duration more than 2 hours under general anaesthesia will be enrolled.

Exclusion Criteria

  • •1.Patient undergoing cardio-thoracic surgery, thoracotomies 2.Patients with active upper or lower airway infection 3.Patients with abnormal preoperative chest Xâ€ray findings 4.Patients who are likely to require postoperative mechanical ventilation 5.Morbidly obese patients (BMI-35Kg/m2).

Outcomes

Primary Outcomes

To compare the incidence and severity of postoperative atelectasis determined by CT thorax.

Time Frame: To compare the incidence and severity of postoperative atelectasis during postoperative period upto 24hrs determined by CT thorax.

Secondary Outcomes

  • 1.To compare postoperative gas exchange by PaO2/FIO2.(before preoxygenation and postoperatively at 1-hour, 6-hours and 12-hours)
  • 2.To compare incidence of postoperative nausea and vomiting.(24 hours postoperatively.)
  • 3.To compare incidence of surgical site infection.(Till 5 days postoperatively.)
  • 4.To compare requirement of postoperative respiratory support (oxygen supplementation/ mechanical ventilation).(Till day 3 postoperatively.)
  • 5.To compare incidence of postoperative pneumonia.(Till day 3 postoperatively.)

Investigators

Sponsor
All India Institute of Medical Sciences AIIMS Jodhpur
Sponsor Class
Government medical college

Study Sites (1)

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