Comparison of modes of ventilation in spine surgery in prone position.

Phase 4

Not yet recruiting

• Conditions: Malignant neoplasm of spinal cord, (2) ICD-10 Condition: D334||Benign neoplasm of spinal cord, (3) ICD-10 Condition: S220||Fracture of thoracic vertebra, (4) ICD-10 Condition: S320||Fracture of lumbar vertebra, (5) ICD-10 Condition: S331||Subluxation and dislocation of lumbar vertebra,

• Registration Number: CTRI/2019/08/020811
• Lead Sponsor: Department of Anaesthesiology and Critical Care

Brief Summary

The aim and objectives of the thesis is comparison of two modes of mechanical ventilation – volume control andpressure control in spine surgery patients in prone position. Adult patients aged 18 to 60 years, of either sex,belonging to ASA physical status I – IIscheduled to undergo thoracolumbar spine surgery (for tumors or trauma) inprone position under general anaesthesia will be enrolled in the study. Total of 74 patients (37 in each group) will be studied. Respiratorymechanics (peak airway pressure, plateau pressure, lung compliance, dead spaceand oxygenation), haemodynamicparameters (heart rate, blood pressure) and pulmonaryfunction tests (vital capacity, peak expiratory flow rate, forced expiratoryvolume in first second) will be assessed. Data will be compiled and appropriate statistical tests will be used to analyse the result.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-08-20
• Study Start: 2019-08-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Adult patients aged 18 to 60 years, of either sex, belonging to ASA physical status I – II scheduled to undergo thoracolumbar spine surgery (for tumors or trauma) in prone position under general anesthesia will be enrolled in the study.

Exclusion Criteria

Patients having Bronchopulmonary disease (like asthma, chronic bronchitis, emphysema), Cardiac disease, BMI >30 kg/m2, Cerebrovascular disease, Neuromuscular disorder and Multiple trauma will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Pulmonary function tests (Vital capacity, Peak expiratory flow rate, forced expiratory volume in first second).	Respiratory mechanics will be assessed for both pressure control and volume control ventilation intraoperatively. PFTs will be done preoperatively the same day as baseline, intraoperatively and one day postoperatively only. The above data will be compiled and appropriate statistical test will be used to analyse the results.
1. Respiratory mechanics (peak airway pressure, plateau pressure, lung compliance, dead space and oxygenation).	Respiratory mechanics will be assessed for both pressure control and volume control ventilation intraoperatively. PFTs will be done preoperatively the same day as baseline, intraoperatively and one day postoperatively only. The above data will be compiled and appropriate statistical test will be used to analyse the results.

Secondary Outcome Measures

Name	Time	Method
Haemodynamic parameters (Heart rate, blood pressure, SpO2)	The above outcome will be assessed for both pressure control and volume control ventilation intraoperatively only. Data will be compiled and appropriate statistical test will be used to analyse the results.

Trial Locations

Locations (1)

Pt. B. D. Sharma, PGIMS, Rohtak; 🇮🇳 Rohtak, HARYANA, India

Pt. B. D. Sharma, PGIMS, Rohtak

🇮🇳Rohtak, HARYANA, India

Dr Poonam Godhwal

Principal investigator

9968646162

godhwalpoonam@yahoo.in