Hemodynamics InstabilityNCT03027817
Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery
An observational study of Hemodynamics Instability, run by Dhritiman Chakrabarti.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodynamics Instability
- What is being tested?
- Prone Positioning
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Cervical Myelopathy undergoing elective cervical decompression in prone position.
Who may be able to join
- 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
Who cannot join
- Atlanto occipital dislocation and cervicomedullary junction pathology
- Tumour pathology
- Diabetic patients
- Patients positioned prone in the awake state (without induction of anaesthesia)
About this study
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.
Read more
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
- Being tested
- Prone Positioning
- Keywords
- Prone positioning, Non-invasive Cardiac Output Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningProcedure or surgery
Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Secondary outcomes (5)
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.
Measured: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
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.
Measured: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
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.
Measured: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
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.
Measured: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
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.
Measured: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamics InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhritiman Chakrabarti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- Nitin Manohar, MD, DNB, DM, Principal investigator, National Institute of Mental Health and Neuro Sciences, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027817
- Sponsor's protocol ID
- NIMHANS
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via email shared on this portal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output and Other Hemodynamic Changes With Prone Position in Cervical Myelopathy Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03027817
- Acronym / sponsor ID
- NIMHANS
- Conditions
- Hemodynamics Instability
- Keywords
- Prone positioning, Non-invasive Cardiac Output Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dhritiman ChakrabartiUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Cervical Myelopathy undergoing elective cervical decompression in prone position.
Key inclusion criteria (4 listed)
- ASA Class I , II and III
- Age between 18 to 65 years
- Nurick's grade 2 or more
Key exclusion criteria (4 listed)
- Atlanto occipital dislocation and cervicomedullary junction pathology
- Tumour pathology
- Diabetic patients
- Patients positioned prone in the awake state (without induction of anaesthesia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone PositioningNoninvasive cardiac output monitoring parameters were recorded before and after prone positioning. | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
Heart rate
Time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Cardiac output
Time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Stroke volume
Time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Stroke volume variation
Time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Total peripheral resistance
Time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers. If required, the Sponsor-Investigator may be contacted via email shared on this portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Manohar, MD, DNB, DM principal investigator
National Institute of Mental Health and Neuro Sciences, Bangalore
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamics Instability, run by Dhritiman Chakrabarti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial pressure (time frame: Before induction of anaesthesia to 20 minutes after prone positioning (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.