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

Influence of intraoperative liberal Vs. conservative O2 fraction on pulmonary function in healthy adults undergoing spine surgery,a randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034824

Enrollment

Registered

2021-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

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

Interventions

Intervention1: Fiow 0.3: Conservative FiO2 of 0.3 with air Control Intervention1: 0.8 FiO2: Liberal FiO2 0.8 with air

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
. To compare the changes in PaO2/FiO2 at the end of anaesthesia in between group A (FiO2 0.3 with 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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Shyam Charan Meena

PGIMER, Chandigarh

drshyam.pgi@gmail.com7891669817

Outcome results

None listed

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