Pulse Transit Time in Anesthetized Patients: Blood Pressure or Cardiac Output as Measured With NICOM Monitor (PuTT-NICOM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pizov Reuven, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01259687
First received: December 7, 2010
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

Pulse transit time (PuTT) - the time between R wave on ECG and initiation of upstroke in the peripheral arterial waveform - described in the previous studies as value that reflects changes in both blood pressure and blood volume. The investigators are assuming that PuTT changes reflect the dynamic of systolic blood pressure but not cardiac output fluctuations.


Condition Intervention
Anesthetized Ventilated Patients
Device: Non-invasive cardiac output monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulse Transit Time in Anesthetized Ventilated Patients: Affect of Blood Pressure or Cardiac Output as Measured With NICOM Monitor

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Pulse transit time (PuTT) [ Time Frame: Two minutes after each intervention (giving Nitroglycerine, Phenylephrine or Fluid loading) ] [ Designated as safety issue: No ]
    Simultaneous record of arterial line waveform and ECG will be made just before and 2 minute after giving one of treatments (Phenylephrine, Nitroglycerine or fluid bolus). PuTT will be measured offline from the record


Enrollment: 63
Study Start Date: January 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study group Device: Non-invasive cardiac output monitoring
During the surgery the continuous monitoring of blood pressure by peripheral artery catheter and cardiac output by NICOM (non-invasive cardiac output monitoring) will be applied. In case of intraoperative hemodynamic changes (hypertension, hypotension) the patient will be treated according to the standard care by Phenylephrine, Nitroglycerine or Colloid fluid boluses. Cardiac output will be measured by NICOM just before and after each treatment of hemodynamic events that described above. Simultaneous records of ECG, arterial and plethysmographic waveforms will be made just before and after each event. Systolic blood pressure and PuTT will be measured OFFLINE from the recorded waveforms
Other Names:
  • Cheetah Reliant
  • NICOM
  • Cheetah Medical

Detailed Description:

Background Pulse transit time (PuTT) - the time between R wave on ECG and initiation of upstroke in the peripheral arterial waveform - described in the previous studies as value that reflects changes in both blood pressure and blood volume. We are assuming that PuTT changes reflect the dynamic of systolic blood pressure but not cardiac output fluctuations.

Clinical trial objectives Investigate a link between PuTT (Pulse transit time) and changes in blood pressure and cardiac output measured by non-invasive cardiac output monitoring device (NICOM).

Endpoints PuTT Blood pressure: systolic, diastolic, mean Heart rate Cardiac output-Index Systemic vascular resistance-Index

Prospective nonrandomized clinical trial

Inclusion criteria Need for continuous invasive monitoring of blood pressure - according to the type of surgery the patient's health status Normal sinus rhythm

Exclusion criteria Pregnancy Cave to Nitroglycerine or Phenylephrine Chronic renal failure with creatinine level above 2 mg%

Safety assessment methods Monitoring of cardiac output is one of the most important elements of hemodynamic monitoring. In the past this monitoring was based mainly on the invasive and awkward methods causing usage only in exceptional cases. NICOM device allows accurate non-invasive monitoring of cardiac output During anesthesia patient care changes are made according to changes in vital indicators such as blood pressure, pulse, cardiac output. So during the study, anesthesia care can be affected by the indices obtained using a NICOM.

Data processing and analysis During the surgery the continuous monitoring of blood pressure by peripheral artery catheter and cardiac output by NICOM will be applied.

In case of hemodynamic changes the patient will be treated according to the standard care:

In case of decrease of systolic blood pressure below 80 mmHg (in the patients with history of arterial hypertension - below 90 mmHg) and HR is above 70 bpm the patient will be treated by repeated boluses of Phenylephrine 50-100 mcg until the systolic blood pressure will increase by at least 20%.

Intraoperative hypertension above 160 mmHg will be treated by repeated boluses of Nitroglycerine 100 mcg until the systolic blood pressure will decrease by at least 20%.

Hypovolemia will be treated by boluses of colloid solution - HAES 6% - at dose of 7 ml/kg of body mass during 15 min.

Study procedures

Cardiac output will be measured by NICOM just before and after each treatment of hemodynamic events that described above. Simultaneous records of ECG, arterial and plethysmographic waveforms will be made just before and after each event.

Systolic blood pressure and PuTT will be measured OFFLINE from the recorded waveforms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing various types elective surgery which require continous invasive monitoring of blod pressure

Criteria

Inclusion Criteria:

  • All patients scheduled for elective surgery and require invasive monitoring of blood pressure according to their medical condition and type of surgery

Exclusion Criteria:

  • Patients under the age of 18
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01259687

Locations
Israel
Carmel Medical Center
Haifa, Israel, 34362
The Lady Davis Carmel Medical Center
Haifa, Israel, 34382
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Reuven Pizov, MD Carmel Medical Center
  More Information

No publications provided

Responsible Party: Pizov Reuven, MD, Clinical Professor of Anesthesiology, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01259687     History of Changes
Other Study ID Numbers: CMC-09-0124-CTIL
Study First Received: December 7, 2010
Last Updated: November 23, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
Electrocardiogram
Arterial line waveform
Cardiac output

ClinicalTrials.gov processed this record on September 30, 2014