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Comparison of the role of increased versus decreased oxygen supply during and after surgery in reduction of Surgical Site Infection in patients undergoing emergency exploratory laparotomy: A prospective double blinded single centre non inferiority randomised control trial

Comparison of the role of 40 percent fraction of inspired oxygen versus 80 percent fraction of inspired oxygen perioperatively in reduction of Surgical Site Infection in patients undergoing emergency exploratory laparotomy: A prospective double blinded single centre non inferiority randomised control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043548
Enrollment
134
Registered
2022-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: K352- Acute appendicitis with generalized peritonitis Health Condition 2: K251- Acute gastric ulcer with perforation Health Condition 3: K650- Generalized (acute) peritonitis Health Condition 4: K566- Other and unspecified intestinal obstruction Health Condition 5: K631- Perforation of intestine (nontraumatic)

Interventions

Intervention1: 80 percent FiO2 perioperatively: Patients in the intervention arm will receive inspired oxygen at a concentration of 80 percent after endotracheal intubation (FiO2 of 0.80). After emerg

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-65 years 2. ASA I or II 3. Undergoing emergency laparotomy for perforation peritonitis or obstruction

Exclusion criteria

Exclusion criteria: 1. Patients 65 years 2. Patients who cannot maintain saturation >90% in room air in the preoperative period 3. Patients who are intubated before induction due to respiratory failure 4. Patients who cannot be extubated in the post operative period 5. Patients with a known history of chronic respiratory/cardiac disease 6. Patients with moderate or severe COVID Disease 7. Patients who are currently pregnant 8. Patients unwilling to participate in the study

Design outcomes

Primary

MeasureTime frame
1. Incidence of deep and organ space SSI within 30 postoperative days [Day 0 being the day of the procedure]Timepoint: 30 postoperative days

Secondary

MeasureTime frame
Admission to ICUTimepoint: 14 postoperative days;ASEPSIS ScoreTimepoint: 30 postoperative days;Incidence of pulmonary complications causing symptoms of atelectasis, pneumonia, respiratory failureTimepoint: 14 postoperative days;Post operative duration of hospital stayTimepoint: 30 postoperative days;Re-operationTimepoint: 14 postoperative days

Countries

India

Contacts

Public ContactDr Pravanjan Behera

All India Institute of Medical Sciences, Bhubaneswar

surg_bikram@aiimsbhubaneswar.edu.in8763278543

Outcome results

None listed

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