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NCT Number: NCT03027817

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)

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Key information

Conditions

Hemodynamics Instability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prone positioning

Procedure

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

Primary outcomes

  1. Mean arterial pressure

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

    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.

Secondary outcomes

  1. Heart rate

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

    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.

  2. Cardiac output

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

    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.

  3. Stroke volume

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

    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.

  4. Stroke volume variation

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

    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.

  5. Total peripheral resistance

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

    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.

Sponsors and collaborators

Lead sponsor

Dhritiman Chakrabarti

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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