Clinical trial NCT03027817: Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery
Official title: Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics Instability
Keywords: Prone positioning
Non-invasive Cardiac Output Monitoring
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Cervical Myelopathy undergoing elective cervical decompression in prone position.

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)


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)

Primary outcomes:
measure: Mean arterial pressure
timeFrame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Secondary outcomes:
measure: Heart rate
timeFrame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
measure: Cardiac output
timeFrame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
measure: Stroke volume
timeFrame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
measure: Stroke volume variation
timeFrame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
measure: Total peripheral resistance
timeFrame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Mental Health and Neuro Sciences, Bangalore
name: Nitin Manohar, MD, DNB, DM
role: PRINCIPAL_INVESTIGATOR
References: