Evaluation of Hemodynamic and Ventilatory Effects of Nega... | NCT06088966

Studies
Evaluation of Hemodynamic and Ventilatory Effects of Negative Pressure Ventilation

NCT06088966

Sponsor

Karlsburg Hospital

Status

Unknown status

Last Update Posted

Oct 18, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cardiac Output, Low

Interventions

Not provided

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Oct 3, 2023

First Submission Date that Met QC Criteria

Oct 11, 2023

First Posted Date

Oct 18, 2023Actual

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

Oct 11, 2023

Last Update Posted Date

Oct 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Matthias Heringlake, Clinical Professor and head of the department of anesthesiology and intensive care Prof. Dr. Matthias Heringlake, Karlsburg HospitalPrincipal Investigator

Lead Sponsor

Karlsburg HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.

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

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

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke Volume Index in ml/m2		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Heart rate in beats/min		1 hour
blood pressure in mm/Hg		1 hour
arterial oxygen saturation in %

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with pulmonary artery catheter after cardiac surgery

Exclusion Criteria:

minimally invasive surgery
unstable conditions
bleeding
unability to fit cuirass

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients after surgery without exclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthias Heringlake, Prof. Dr.	Contact	004938355700		anaesthesie.karlsburg@klinikumkarlsburg.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Karlsburg, Klinik für Anästhesiologie	Recruiting	Karlsburg	Mecklenburg-Vorpommern	17495	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40744972	Derived	Schemke S, Grunewald H, Schemke L, Franzen K, Hirschl D, Heringlake M, Muras L. A pilot study on the hemodynamic effects of negative pressure ventilation in patients after cardiac surgery focussing on right ventricular function. Sci Rep. 2025 Jul 31;15(1):27974. doi: 10.1038/s41598-025-12534-1.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms