Inert Gas Rebreathing in Ventilated Patients

Heart Failure Clinical Trial

— VIGR  

Official title:

Feasibility of the Non-invasive Determination of Cardiac Output Using Inert Gas Rebreathing in Ventilated Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01891253
• Other study ID #: VIGR_MA
• Status: Active, not recruiting
• Start date: March 2013
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Measuring hemodynamic parameters in ventilated patients is important yet still complicated to perform. Inert gas rebreathing (IGR) showed promising results when being compared to other invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of our study is to evaluate the feasibility of IGR in ventilated patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18 - 80 years

• mechanically ventilated patient

• existing PiCCO arterial line

Exclusion Criteria:

• FiO2 > 60% (fraction of inspired oxygen)

• PEEP > 10 mmHg (positive end-expiratory pressure)

• SO2 < 90% (oxygen saturation )

• Systolic blood pressure < 90 mmHg

• Heart rate > 150 bpm

• APRV (airway pressure release ventilation)

• ICD (implantable cardioverter defibrillator) / pace maker

• [ Anaesthetic Conserving Device (Anaconda) ]

Related Conditions & MeSH terms

• Heart Failure
• Renal Failure
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis

Intervention

Device:
• non-invasive determination of cardiac output

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mannheim	Manheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac output	Determination of cardiac output using invasive pulse contour analysis (PiCCO) and non-invasive inert gas rebreathing (Innocor)	1 day