Pulse Transit Time in Anesthetized Patients: Blood Pressure or Cardiac Output as Measured With NICOM Monitor (PuTT-NICOM)
|ClinicalTrials.gov Identifier: NCT01259687|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : November 26, 2013
|Condition or disease||Intervention/treatment|
|Anesthetized Ventilated Patients||Device: Non-invasive cardiac output monitoring|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||63 participants|
|Official Title:||Pulse Transit Time in Anesthetized Ventilated Patients: Affect of Blood Pressure or Cardiac Output as Measured With NICOM Monitor|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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
- Pulse transit time (PuTT) [ Time Frame: Two minutes after each intervention (giving Nitroglycerine, Phenylephrine or Fluid loading) ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259687
|Carmel Medical Center|
|Haifa, Israel, 34362|
|The Lady Davis Carmel Medical Center|
|Haifa, Israel, 34382|
|Principal Investigator:||Reuven Pizov, MD||Carmel Medical Center|