A New Method for Estimating Dynamic Intrinsic PEEP (echoPEEPi)

December 28, 2015 updated by: dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna

A New Method for Estimating Dynamic Positive End-expiratory Pressure. Description and Validation With PEEPi Dyn Measured With Transdiaphragmatic Pressure

Dinamic intrinsic PEEP is

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dynamic intrinsic positive end-expiratory pressure (PEEPi dyn) play an important pathophysiology role in many acute respiratory pathologies.

The most accurate method to quantify PEEPi dyn is to measure the rise in transdiaphragmatic pressure (Pdi) at end expiration at the point of the contraction of the inspiratory muscles until inspiratory flow starts.

Such method, however, is invasive, poor comfortable and require patient active collaboration.

The purpose of this study is describe a new non-invasive method for estimate PEEPi dyn and validate this method with gold-standard-one.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40185
        • Sant'Orsola Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with both acute or chronic respiratory insufficiency, who required respiratory mechanics measurements for clinical purpose.

Description

Inclusion Criteria:

  • Acute or chronic respiratory failure
  • Age >=18 y

Exclusion Criteria:

  • Lack of informed consent
  • Controindication to the placement of oesophageal and gastric catheter:

esophageal varices, gastric or oesophageal bleeding in the previous 30 days, gastric or oesophageal surgery in the preceding year.

  • Cardiac arrest
  • Severe emodinamic instability (> 1 vasoacttive drug)
  • Acute coronary syndrome (AMI/UA)
  • Inability to protect airway
  • Respiratory arrest
  • Pregnancy suspected or confirmed
  • Diaphragm palsy
  • Curarization in the preceding five hours
  • Mechanical ventilation in controlled mode.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements.
Time Frame: 20 minutes
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation and agreement between neural inspiratory time and ecographic inspiratory time
Time Frame: 10 minutes
10 minutes
Inter-rater agreement to assest method reliability
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/2015/O/Sper

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Insufficiency

Clinical Trials on diaphragm ecography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe