Hemodynamic Measurements at Different Inclinations of the Head (HMDIH)

January 24, 2014 updated by: Rosangela de Oliveira Felice, Federal University of Uberlandia

Comparison of CVP Values , ΔPP and Echocardiographic at Different Angles Headwaters Before and After Volume Challenge

The purpose of this study is to determine whether hemodynamic measures vary in angles bedside before and after volume challenge.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Check if values of central venous pressure (CVP), pulse pressure variation (Δpp), heart rate (HR), mean arterial pressure ((PAM) vary in different angles headboards
  • Compare values of CVP, Δpp, HR and MAP as predictors of blood volume after supply of 500 ml of 0.9% saline solution.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 38405-382
        • Recruiting
        • Intensive Care Unit, Clinical Hospital, Federal University of Uberlandia
        • Contact:
        • Principal Investigator:
          • Rosangela O Felice, Expert
        • Sub-Investigator:
          • Elmiro S Resende, Doctor
        • Sub-Investigator:
          • Thulio M Cunha, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being in circulatory shock and have at least one of the following criteria to identify loss of tissue perfusion: systolic blood pressure <90 mmHg or need for vasoactive drugs, urine output below 0.5 ml / kg / h.
  • Being under sedation, assessed by the scale of Richmond agitation and sedation (RASS) -5, mechanically ventilated in volume control mode with tidal volume between 8 to 12 ml/kg, PEEP to 8 cm H2O.
  • Tue signing the informed consent by legal guardian.

Exclusion Criteria:

  • Presence cardiac arrhythmias.
  • Presence of abdominal or thoracic trauma.
  • Contraindication for passive elevation of the members.
  • Hypoxia significant PaO2/FiO2 < or equal 100.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 0.9% saline solution
comparing values obtained before and after administration of 500 ml of 0.9% saline
Other: 0.9% saline solution
comparing values obtained before and after administration of 500 ml of 0.9% salin
Other Names:
  • Solution of 0.9% NaCl in distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Different Backrest position's effect on CVP, CO and ∆PP measures
Time Frame: Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014.
Data collection was performed at admission or within 10 days of hospitalization between September 2013 and February 2014.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Uberlandia

Investigators

  • Principal Investigator: Rosangela O Felice, expert, Federal University of Uberlandia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

January 24, 2014

First Posted (ESTIMATE)

January 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hemodinamica

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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