Physiologic Effects of CPAP After Vascular Surgery | NCT03543930

Studies
Physiologic Effects of CPAP After Vascular Surgery

NCT03543930

Sponsor

University of Genova

Status

Unknown status

Last Update Posted

Jul 3, 2018Actual

Enrollment

18Estimated

Phase

Not provided

Conditions

Postoperative Complications
Respiratory Failure

Interventions

Postoperative preventive CPAP

Countries

Italy

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

Jun 2018

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

May 25, 2018Actual

Primary Completion Date

May 25, 2019Estimated

Completion Date

Jul 1, 2019Estimated

First Submitted Date

May 18, 2018

First Submission Date that Met QC Criteria

May 18, 2018

First Posted Date

Jun 1, 2018Actual

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

Jun 29, 2018

Last Update Posted Date

Jul 3, 2018Actual

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

This study aims to investigate, with a case-crossover design, the effects of a short course of preventive CPAP administered in the immediate postoperative period in patients at high-risk of developing postoperative pulmonary complications undergoing major vascular surgery.

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

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Major open vascular surgery		Surgical procedures on the abdominal aorta requiring median abdominal incision	Device: Postoperative preventive CPAP
Endovascular aortic repair		Abdominal aortic repair with endovascular approach	Device: Postoperative preventive CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Postoperative preventive CPAP	Device	Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2	Endovascular aortic repair Major open vascular surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PaO2/FIO2 ratio	Increase of the PaO2/FIO2 ratio compared to the baseline value	Two hours after the administration of CPAP

Secondary Outcomes

Measure	Description	Time Frame
Esophageal pressure-time product (PTPes)	Increase of the PTPes compared to the baseline value	Two hours after the administration of CPAP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Open or endovascular surgery on the abdominal aorta
Surgical procedure requiring general anaesthesia and invasive intraoperative mechanical ventilation
Intermediate-high risk of postoperative pulmonary complications (ARISCAT score ≥ 26)

Exclusion Criteria:

Prolonged post-operative invasive ventilation
Invasive or non-invasive ventilation or oxygen therapy in the last month
ASA class IV or V
Emergency procedures
Pneumothorax or active pulmonary infection
Any contraindication to CPAP
Prolonged bed rest
Patient refusal to participate or to receive preventive CPAP

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

Consecutive patients undergoing vascular surgical procedures on the abdominal aorta with open or endovascular approach

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Pelosi, Prof.	Contact	+39 335 5941740‬		ppelosi@hotmail.com

Overall Officials

Name	Affiliation	Role
Lorenzo Ball, MD	Università degli Studi di Genova	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico San Martino	Recruiting	Genova		16132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

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Browse Branches

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