Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery

Positioning a patient in prone position under anaesthesia significantly alters cardiovascular physiology. Cervical myelopathy patients are known to have autonomic dysfunction. Such patients when positioned in prone position under anaesthesia carry a higher risk of developing hemodynamic changes and this can compromise spinal cord perfusion.

This prospective observational study was conducted on 30 patients with cervical myelopathy who underwent surgery in prone position at NIMHANS, Bangalore hospital. The non invasive cardiac output monitor (NICOM, Cheetah Medicals) was used to record various hemodynamic parameters. The hemodynamic parameters were recorded at baseline, post induction, post intubation, prior to prone position, post prone position, and every five minutes thereafter upto 20mins.

The hemodynamic parameters that were recorded using the NICOM monitor:

• HR - Heart rate (beats /min)
• NIBP - non invasive blood pressure (mmHg)
• MAP - mean arterial pressure(mmHg)
• CO - cardiac output (l/min)
• CI - cardiac index (l/min/m2)
• SV - Stroke volume (ml/beat)
• SVV -stroke volume variability (%)
• TPR - total peripheral resistance (dynes. sec/cm5)

Study Overview

• Status: Completed
• Conditions: Hemodynamics Instability
• Intervention / Treatment: Procedure: Prone Positioning

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Cervical Myelopathy undergoing elective cervical decompression in prone position.

Description

Inclusion Criteria:

Cervical myelopathy patients undergoing surgery in prone position with:

• ASA Class I , II and III
• Age between 18 to 65 years
• Nurick's grade 2 or more

Exclusion Criteria:

• Atlanto occipital dislocation and cervicomedullary junction pathology
• Tumour pathology
• Diabetic patients
• Patients positioned prone in the awake state (without induction of anaesthesia)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	Analysis of change in mean arterial pressure at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.	Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Analysis of change in heart rate at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.	Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Cardiac output	Analysis of change in cardiac output at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.	Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Stroke volume	Analysis of change in stroke volume at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.	Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Stroke volume variation	Analysis of change in stroke volume variation at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.	Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Total peripheral resistance	Analysis of change in total peripheral resistance at following time points - before induction of anaesthesia, 2 minutes after anaesthetic induction, 2 minutes after intubation, before turning prone, immediately after turning prone and every 5 minutes thereafter till 20 minutes after positioning.	Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

Collaborators and Investigators

• Sponsor: Dhritiman Chakrabarti
• Investigators: Principal Investigator: Nitin Manohar, MD, DNB, DM, National Institute of Mental Health and Neuro Sciences, Bangalore

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Prone positioning; Non-invasive Cardiac Output Monitoring
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: NIMHANS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via email shared on this portal.