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Comparing the effect of two commonly used mechanical ventilatory strategies in patients undergoing surgeries for spine disorders with regard to the exchange of gases we breathe out and in, namely carbon dioxide and oxygen,when the patient is being operated in the flipped position(lying face down)

Comparing the effect of low volume ventilation (6ml/kg with PEEP 5) with traditional ventilation (10 ml/kg without PEEP) strategies on intraoperative ventilation and oxygenation indices in patients undergoing spine surgeries in prone position

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009187
Enrollment
56
Registered
2017-07-31
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: null- ASA (American Society of Anaesthesia) physical status 1 & 2 adult patients with a BMI (body mass index) between 18 to 35 undergoing spinal surgical procedures under general anaesthesia with IPPV Health Condition 2: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: tidal volume of 6 ml/kg with 5 cm H2O PEEP: Comparing the low volume ventilation which is a tidal volume of 6ml per kg with a PEEP of 5 cm H2O, which will be generated by the anaesthesi

Sponsors

IRB Research office
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA (American Society of Anaesthesia) physical status 1 & 2 adult patients with a BMI (body mass index) between 18 to 35 undergoing spinal surgical procedures under general anaesthesia with IPPV

Exclusion criteria

Exclusion criteria: 1. ASA physical status 3 & 4; 2. Age less than 18 years or more than 75 years; 3. Known case of bronchial asthma, COPD (chronic obstructive pulmonary disease), or other respiratory pathology; 4. Pre-existing acid-base abnormality; 5. Patients with a history of smoking; 6. Emergency procedures; 7. Procedures involving thoracotomy or alteration of ventilatory parameters for surgical purposes; 8. Procedures expected to last for less than 2 hours duration; 9. Refusal / inability to give consent

Design outcomes

Primary

MeasureTime frame
To determine the adequacy of ventilation based on 1. ETCO2 remaining within allowable limits. 2. Change in the PaCO2 value at the end of 2 hours of ventilation in prone position Timepoint: 8 months. October 2nd 2017. But i will be providing data of the total number of patients enrolled in a month, to the review board on a monthly basis.—

Secondary

MeasureTime frame
To check the change in oxygenation indices 1. Change in the PAO2-PaO2 gradient, 2. Change in the PAO2-FiO2 ratio, Timepoint: 8 months. October,2nd 2017—

Countries

India

Contacts

Public ContactAmitav Philip

Christian Medical college , Vellore

sajanpg@cmcvellore.ac.in8940458265

Outcome results

None listed

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