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Trial record 67 of 81394 for:    measured

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

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ClinicalTrials.gov Identifier: NCT01259687
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Pizov Reuven, Carmel Medical Center

Tracking Information
First Submitted Date December 7, 2010
First Posted Date December 14, 2010
Last Update Posted Date November 26, 2013
Study Start Date January 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 13, 2010)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01259687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulse Transit Time in Anesthetized Patients: Blood Pressure or Cardiac Output as Measured With NICOM Monitor
Official Title Pulse Transit Time in Anesthetized Ventilated Patients: Affect of Blood Pressure or Cardiac Output as Measured With NICOM Monitor
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients undergoing various types elective surgery which require continous invasive monitoring of blod pressure
Condition Anesthetized Ventilated Patients
Intervention 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
Study Groups/Cohorts Study group
Intervention: Device: Non-invasive cardiac output monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 23, 2013)
63
Original Estimated Enrollment
 (submitted: December 13, 2010)
150
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01259687
Other Study ID Numbers CMC-09-0124-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pizov Reuven, Carmel Medical Center
Study Sponsor Carmel Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Reuven Pizov, MD Carmel Medical Center
PRS Account Carmel Medical Center
Verification Date November 2013