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

NCT03027817 | Completed

• 1 other identifier: NIMHANS
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

Prone positioning; Non-invasive Cardiac Output Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Heart rate

  Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

• Cardiac output

  Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

• Stroke volume

  Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

• Stroke volume variation

  Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

• Total peripheral resistance

  Before induction of anaesthesia to 20 minutes after prone positioning (end of study)

Interventions

Prone Positioning PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dhritiman Chakrabarti: lead

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nitin Manohar, MD, DNB, DM

  National Institute of Mental Health and Neuro Sciences, Bangalore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neuroanaesthesiology

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share