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

Hemodynamics Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027817
• Other study ID #: NIMHANS
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: January 20, 2017
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemodynamics Instability
• Spinal Cord Diseases

Intervention

Procedure:
• Prone Positioning
Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dhritiman Chakrabarti

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)