Inert Gas Rebreathing in Ventilated Patients | NCT01891253

Studies
Inert Gas Rebreathing in Ventilated Patients

NCT01891253

Sponsor

Universitätsmedizin Mannheim

Status

Unknown status

Last Update Posted

Sep 25, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Sepsis
Respiratory Failure
Heart Failure
Renal Failure

Interventions

non-invasive determination of cardiac output

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 20, 2013

First Submission Date that Met QC Criteria

Jul 2, 2013

First Posted Date

Jul 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2019

Last Update Posted Date

Sep 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joachim Saur, Priv.-Doz. Dr. med., Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ventilated patients		ventilated patients in an internal medicine ICU with existing PiCCO invasive hemodynamic monitoring	Device: non-invasive determination of cardiac output

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive determination of cardiac output	Device		ventilated patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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) ]

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

ventilated ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Saur, MD	Universitätsmedizin Mannheim	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin Mannheim		Manheim	Baden-Wurttemberg	68167	Germany

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012131	Respiratory Insufficiency
D006333	Heart Failure
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided