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NCT02388282 Clinical Trial

A New Method for Estimating Dynamic Intrinsic PEEP

Respiratory Insufficiency Clinical Trial

— echoPEEPi  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02388282
Other study ID # 7/2015/O/Sper
Secondary ID
Status Completed
Phase N/A
First received March 9, 2015
Last updated December 28, 2015
Start date April 2015
Est. completion date November 2015

Study information
Verified date August 2015
Source Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Contact n/a
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Observational

Clinical Trial Summary

Dinamic intrinsic PEEP is

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• diaphragm ecography
recording of diaphragm ecography

Locations
Country Name City State
Italy Sant'Orsola Malpighi Bologna

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation and agreement between AutoPEEP recorded with the transdiaphragmatic pressure (Pdi) vs ecography measurements. 20 minutes No
Secondary Correlation and agreement between neural inspiratory time and ecographic inspiratory time 10 minutes No
Secondary Inter-rater agreement to assest method reliability 10 minutes No
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