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NCT03281473 Clinical Trial

Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients

Acute Respiratory Distress Syndrome Clinical Trial

— ELSE  

Official title:
Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03281473
Other study ID # 49RC17_0220
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2018
Est. completion date December 2019

Study information
Verified date March 2019
Source University Hospital, Angers
Contact Study Official is required by the WHO and BELONCLE, Ass.Pr
Phone 0241353845
Email Francois.Beloncle@chu-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims at assessing the short-term physiological effects of 2 positive end expiratory pressure titration strategies in patients with ARDS.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age> 18 years

- Moderate or severe ARDS

- Consent to participation obtained from a relative

Exclusion Criteria:

- Protect adult

- Pregnant or breastfeeding woman

- No-affiliation to the social security scheme

- Contra-indication to the placement of an esophageal pressure measuring catheter

- Pneumothorax

- Hemodynamic and / or respiratory instability

- Extra-corporeal membrane oxygenation

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

Intervention

Other:
• Strategy 1
PEEP titration according to transpulmonary-end-expiratory pressure
• Strategy 2
PEEP titration according to chest wall elastance measurement

Locations
Country Name City State
France University Hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Short-term effects of 2 PEEP titration strategies on gas exchange 2 hours 15 minutes
Secondary Short-term effects of 2 PEEP titration strategies on respiratory mechanics 2 hours 15 min
Secondary Short-term effects of 2 PEEP titration strategies on hemodynamics 2 hours 15 min
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