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Trial record 50 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Comparison of Positive End Expiratory Pressure Titration Methods in ARDS Patients (ELSE)

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ClinicalTrials.gov Identifier: NCT03281473
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Other: Strategy 1 Other: Strategy 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Positive End Expiratory Pressure Titration Methods in Patients With Acute Respiratory Distress Syndrome: a Physiological Study
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Arms A
Strategy 1 - Washout period - Strategy 2
Other: Strategy 1
PEEP titration according to transpulmonary-end-expiratory pressure

Other: Strategy 2
PEEP titration according to chest wall elastance measurement

Experimental: Arms B
Strategy 2 - Washout period - Strategy 1
Other: Strategy 1
PEEP titration according to transpulmonary-end-expiratory pressure

Other: Strategy 2
PEEP titration according to chest wall elastance measurement




Primary Outcome Measures :
  1. Short-term effects of 2 PEEP titration strategies on gas exchange [ Time Frame: 2 hours 15 minutes ]

Secondary Outcome Measures :
  1. Short-term effects of 2 PEEP titration strategies on respiratory mechanics [ Time Frame: 2 hours 15 min ]
  2. Short-term effects of 2 PEEP titration strategies on hemodynamics [ Time Frame: 2 hours 15 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281473


Contacts
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Contact: Study Official is required by the WHO and BELONCLE, Ass.Pr 0241353845 Francois.Beloncle@chu-angers.fr

Locations
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France
University Hospital Recruiting
Angers, France
Contact: François BELONCLE, Ass.Pr    0241353845    Francois.Beloncle@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Study Official is required by the WHO and BELONCLE, Ass.Pr Angers teatching hospital

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03281473     History of Changes
Other Study ID Numbers: 49RC17_0220
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
ARDS
Esophageal pressure
Mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury