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

NCT ID: NCT03027817

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-12-31

Brief Summary

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)

Conditions

Hemodynamics Instability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Prone Positioning

Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dhritiman Chakrabarti

OTHER

Sponsor Role: lead

Responsible Party

Dhritiman Chakrabarti

Assistant Professor of Neuroanaesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nitin Manohar, MD, DNB, DM

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neuro Sciences, Bangalore

Other Identifiers

NIMHANS

Identifier Type: -

Identifier Source: org_study_id