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

NCT01259687 | Completed

• 1 other identifier: CMC-09-0124-CTIL
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

Anesthetized Ventilated Patients

Keywords

Electrocardiogram; Arterial line waveform; Cardiac output

Outcome Measures

Primary Outcomes (1)

• Pulse transit time (PuTT)

  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

  Two minutes after each intervention (giving Nitroglycerine, Phenylephrine or Fluid loading)

Study Arms (1)

Study group

Device: Non-invasive cardiac output monitoring

Interventions

Non-invasive cardiac output monitoring 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

Also known as: Cheetah Reliant, NICOM, Cheetah Medical

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients under the age of 18

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (2)

Carmel Medical Center

Haifa, 34362, Israel

Location

The Lady Davis Carmel Medical Center

Haifa, 34382, Israel

Location

Study Officials

• Reuven Pizov, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 14, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

IL (2)