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The effect of two different intraoperative inspired oxygen concentration on postoperative respiratory complications in patients above 60yrs of age undergoing elective surgery under general anesthesia: a randomized-controlled trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036699
Enrollment
48
Registered
2021-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: PCS- Health Condition 2: K638- Other specified diseases of intestine

Interventions

Intervention1: Low fraction of inspired oxygen: Receive inspired 30% oxygen mixed with air Control Intervention1: High Fraction of inspired oxygen: Receive inspired 80% oxygen mixed with air

Sponsors

All India Institute of Medical Sciences AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactPradeep Kumar Bhatia

AIIMS Jodhpur

pk_bhatia@yahoo.com9829159665

Outcome results

None listed

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