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Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress (OLDIA)

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ClinicalTrials.gov Identifier: NCT04520815
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion

Brief Summary:

Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. As such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. Several methods of ultrasound assessment of diaphragm function have been described. Among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. Measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. The etiologies of acute respiratory distress in very elderly patients (i.e.> 75 years) admitted to the emergency reception service are multiple.

To our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. The main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.


Condition or disease
Respiratory Distress Syndrome, Adult

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Assessment of the Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress
Actual Study Start Date : June 24, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022





Primary Outcome Measures :
  1. Presence of diaphragmatic dysfunction [ Time Frame: inclusion ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  2. Presence of diaphragmatic dysfunction [ Time Frame: Day 1 ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  3. Presence of diaphragmatic dysfunction [ Time Frame: Day 3 ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  4. Presence of diaphragmatic dysfunction [ Time Frame: Day 7 ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  5. Presence of diaphragmatic dysfunction [ Time Frame: up to 7 days ]
    Ultrasound measurement of diaphragmatic excursion (ED)


Secondary Outcome Measures :
  1. Inter-observer reproductibility of the measurement of ED and EIT [ Time Frame: Day 0 ]
    Comparison of the measure in the between two operators

  2. Predictive value of the presence of diaphragmatic dysfunction [ Time Frame: 48 hours after the beginning of hospitalization ]
    Ultrasound measurement of diaphragmatic excursion (ED) on the use of ventilatory assistance

  3. Predictive value of the presence of diaphragmatic dysfunction over the average length of hospital stay [ Time Frame: up to 7 days ]
    length of hospitalization duration in Intensive care unit

  4. Predictive value of the presence of a diaphragmatic dysfunction on mortality [ Time Frame: up to 7 days ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  5. Predictive value of the presence of a diaphragmatic dysfunction on mortality [ Time Frame: 6 months after the end of hospitalization ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  6. Kinetics of evolution of the diaphragmatic function [ Time Frame: Day 1 ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  7. Kinetics of evolution of the diaphragmatic function [ Time Frame: Day 3 ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  8. Evolution of the diaphragmatic function [ Time Frame: Day 7 ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  9. Evolution of the diaphragmatic function [ Time Frame: Before 7 days ]
    Ultrasound measurement of diaphragmatic excursion (ED)

  10. Correlation between risk factors for developing diaphragmatic dysfunction (DD) and ultrasound diagnosis of diaphragmatic dysfunction (DD) [ Time Frame: up to 7 days ]
    Identification of the risk factors and Ultrasound measurement of diaphragmatic excursion (ED)

  11. Possible correlation between the presence of a DD diagnosed by the ultrasound measurement of the ED and the duration of mechanical ventilation, the duration of hospitalization in ICU, respiratory complications rate and failures organs rate [ Time Frame: up to 7 days ]
    qSOFA et APACHE II score

  12. Correlation between the presence of DD diagnosed by ultrasound measurement of ED and the evolution of the functional status of the patient at the end of hospitalization compared to his status at the admission [ Time Frame: up to 7 days ]
    scores ADL et AGGIR

  13. Presence of diaphragmatic dysfunction in patients with COVID-19 [ Time Frame: up to 7 days ]
    Ultrasound measurement of diaphragmatic excursion (ED)



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Recruitment of all patients over the age of 75, presenting to adult emergency departments and in spontaneous ventilation and having at least one criterion of acute respiratory distress.
Criteria

Inclusion Criteria:

  • Patient in spontaneous ventilation at the admission on emergency room
  • Presence of acute respiratory distress defined by at least 1 of the following criteria:

    • Respiratory rate > 25/min and/or clinical signs of acute respiratory distress,
    • Hypoxia defined by Sp02 < 90 %,
    • Hypercapnia defined by PaC02 > 45 mmHg with respiratory acidosis defined by a pH value <7.35.
  • Absence of opposition of the patient to his participation in the study and the use of his data or the trusted person if the state of the patient does not allow it.

Exclusion Criteria:

  • Presence of a preexisting diaphragmatic dysfunction appearing in the history or the medical file of the patient and explored on the electro-physiological level,
  • Patient with acute respiratory distress on arrival at the SAU with clinical criteria justifying immediate use of invasive mechanical ventilation and not allowing ultrasound measurements to be carried out or patient admitted to the SAU with mechanical ventilatory support from the outset,
  • Poor command of the French language or state incompatible with the patient's understanding and / or informed adherence to the study protocol,
  • History of surgery involving the integrity of the diaphragmatic muscle (diaphragm plication or diaphragmatic lumpectomy or placement of diaphragmatic pacemaker),
  • Criteria for shock or severe hemodynamic instability,
  • Intra-cranial hypertension.

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): NCT04520815


Contacts
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Contact: Emilie TECHER +2 62 262 90 62 89 emilie.techer@chu-reunion.fr
Contact: Thomas GROSEIL, Dr +262 262 90 60 70 thomasgroseil29@gmail.com

Locations
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France
Centre Hospitalier Universitaire de la Réunion Recruiting
Saint-Denis, France, 97400
Contact: Emilie TECHER    0262946289 ext +262    emilie.techer@chu-reunion.fr   
Principal Investigator: Thomas GROSEIL, PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
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Principal Investigator: Thomas GROSEIL, Dr CHU de La Réunion
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Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT04520815    
Other Study ID Numbers: 2020/CHU/10
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury