How Liberal vs Conservative oxygen fraction influences pulmonary function in healthy adults undergoing spine surgery, a randomized controlled trial.

Phase 1

• Conditions: Health Condition 1: S329- Fracture of unspecified parts of lumbosacral spine and pelvis

• Registration Number: CTRI/2021/07/034824
• Lead Sponsor: PGIMER Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Spine trauma and/or any pathology below fifth thoracic vertebra

2.Scheduled for lower thoracic and/or lumbar spine instrumentation in prone position under

general anaesthesia

3. ASA -I to II physiological status

4. Male, Female or Transgender sex

Exclusion Criteria

ï?· Patient refusal

ï?· Obesity (BMI > 30.0)

ï?· Inability to give informed consent

ï?· Inability to keep arterial oxygen saturation (SpO2) above 90% without supplemental oxygen,

Chemotherapy within 3 months.

ï?· History of any other surgery within 30 days (except surgery under local anaesthesia).

ï?· Known case of respiratory diseases including bronchial asthma, chronic-obstructive

pulmonary disease (COPD), Pulmonary tuberculosis (TB), Pneumonia and others

ï?· Patient with blunt trauma chest and severe brain injury

ï?· Patient with endotracheal and/or chest drain tube.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. To compare the changes in PaO2/FiO2 at the end of anaesthesia in between group A (FiO2 0.3 with <br/ ><br>air) and group B (FiO2 0.8 with air).Timepoint: baseline, 1 hour post induction, 3 hour post extubation and 24 hours post extubation

Secondary Outcome Measures

Name	Time	Method
1. To compare the changes in PaO2/FiO2 at different time intervals in between the groups.Timepoint: baseline, 1 hour post induction, 3 hours post extubation, 24 hours post extubation;2. To compare the changes in lactate values at different time intervals in between the groups.Timepoint: baseline and post extubation 24 hours;4. To observe and record the perioperative hemodynamics, haemoglobin level, pain score etc.Timepoint: baseline, 1 hour post induction, 3 hour post extubation, 24 hour post extubation;5. To compare the C reactive protein (CRP) and Interleukin-6 (IL-6) values in between groups.Timepoint: baseline and 24 hour post extubation;To compare the incidences of PONV and Surgical site infection (SSI) incidence.Timepoint: 6 hours post extubation