Ultrasound of the Diaphragm in ICU Patients | NCT01952262

Studies
Ultrasound of the Diaphragm in ICU Patients

NCT01952262

Sponsor

Università Vita-Salute San Raffaele

Status

Completed

Last Update Posted

Dec 27, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Critically Ill

Interventions

diaphragm ultrasound

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

Dec 2022

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

May 2013

Primary Completion Date

Dec 2022Actual

Completion Date

Dec 2022Actual

First Submitted Date

Aug 2, 2013

First Submission Date that Met QC Criteria

Sep 24, 2013

First Posted Date

Sep 27, 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

Dec 23, 2022

Last Update Posted Date

Dec 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giovanni Landoni, Head of Research, Università Vita-Salute San RaffaelePrincipal Investigator

Lead Sponsor

Università Vita-Salute San RaffaeleOTHER

Collaborators

Not provided

Description Module

Brief Summary

Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients.

Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
critically ill ICU patients		critically ill intensive care unit patients	Other: diaphragm ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diaphragm ultrasound	Other	we'll perform diaphragm ultrasound in ICU critically ill patients	critically ill ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diaphragmatic dysfunction	Diaphragmatic dysfunction will be measured as thickness and inspiratory excursion of the diaphragm	participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or
adults aortic vascular surgery

Exclusion Criteria:

< 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Adult critically ill patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Massimo Zambon, MD	San Raffaele Scientific Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Raffaele di Milano		Milan		20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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