Open Lung PEEP in Thoracic Surgery | NCT03184974

Studies
Open Lung PEEP in Thoracic Surgery

NCT03184974

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Status

Completed

Last Update Posted

Mar 7, 2018Actual

Enrollment

690Actual

Phase

Not provided

Conditions

Thoracic Surgery
Ventilation Therapy; Complications

Interventions

Not provided

Countries

Not provided

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

Mar 2018

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

Oct 1, 2015Actual

Primary Completion Date

Oct 1, 2016Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

Jun 9, 2017

First Submission Date that Met QC Criteria

Jun 9, 2017

First Posted Date

Jun 14, 2017Actual

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

Mar 6, 2018

Last Update Posted Date

Mar 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlos Ferrando, Principal investigador, Fundación para la Investigación del Hospital Clínico de ValenciaPrincipal Investigator

Lead Sponsor

Fundación para la Investigación del Hospital Clínico de ValenciaOTHER

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

During thoracic surgical procedures, while ventilating with a protective tidal volume, an open lung approach consisting of a recruitment maneuver followed by an individualized positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we performed a multicenter observational study in 17 Spanish teaching hospitals of patients undergoing one lung ventilation (OLV). In addition, we analyzed the association between the driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and finally the association between the individualized PEEP and relevant patient preoperative or intraoperative variables.

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

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

690Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative pulmonary complications	Atelectasis, acute respiratory failure, ARDS, pneumonia, reintubation, empyema, bronchospasm, pneumothorax, pneumonitis, bronchopleural fistula	Postoperative. One week

Secondary Outcomes

Measure	Description	Time Frame
Descriptive analysis of the open lung PEEP	Open lung PEEP is the PEEP of best dynamic respiratory system compliance during a PEEP titration trial	intraoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing one lung ventilation

Exclusion Criteria:

No exclusion criteria

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 undergoing one lung ventilation during thoracic surgical procedures

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided