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

NCT ID: NCT01259687

Last Updated: 2013-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-11-30

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.

Conditions

Anesthetized Ventilated Patients

Keywords

Electrocardiogram; Arterial line waveform; Cardiac output

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

Non-invasive cardiac output monitoring

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Cheetah Reliant; NICOM; Cheetah Medical

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pizov Reuven

MD, Clinical Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reuven Pizov, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

The Lady Davis Carmel Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

CMC-09-0124-CTIL

Identifier Type: -

Identifier Source: org_study_id