Use of Mini-fluid Challenge for Fluid Responsiveness Pred... | NCT02858115

Studies
Use of Mini-fluid Challenge for Fluid Responsiveness Prediction During One-lung Ventilation

NCT02858115

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Aug 8, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Acute Circulatory Failure During One-lung Ventilation Surgery

Interventions

Fluid challenge
Trans-oesophageal echography

Countries

France

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Aug 2016Actual

First Submitted Date

Aug 3, 2016

First Submission Date that Met QC Criteria

Aug 5, 2016

First Posted Date

Aug 8, 2016Estimated

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

Aug 5, 2016

Last Update Posted Date

Aug 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation.

This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one lung ventilation lung		patients requiring one lung ventilation lung resection.	Other: Fluid challenge Other: Trans-oesophageal echography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluid challenge	Other	100 ml of crystalloid was infused over 1-min	one lung ventilation lung

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fluid responsiveness	increase of cardiac output of more than 15%	one day
Velocity time index	: Echographic assesment of cardiac output	one day

Secondary Outcomes

Measure	Description	Time Frame
Pulsed pressure variation	dynamic indice of fluid responsiveness	one day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lung resection
Acute circulatory failure
One-lung ventilation

Exclusion Criteria:

Sinusal rhythm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients requiring one lung ventilation lung resection.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
hôpital Nord Assistance Publique Hôpitaux de Marseille		Marseille		13015	France