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

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Recruiting
CT.gov ID
NCT04520815
Collaborator
(none)
100
1
24.2
4.1

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 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 :
    Jun 24, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Jun 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Presence of diaphragmatic dysfunction [inclusion]

      Ultrasound measurement of diaphragmatic excursion (ED)

    2. Presence of diaphragmatic dysfunction [Day 1]

      Ultrasound measurement of diaphragmatic excursion (ED)

    3. Presence of diaphragmatic dysfunction [Day 3]

      Ultrasound measurement of diaphragmatic excursion (ED)

    4. Presence of diaphragmatic dysfunction [Day 7]

      Ultrasound measurement of diaphragmatic excursion (ED)

    5. Presence of diaphragmatic dysfunction [up to 7 days]

      Ultrasound measurement of diaphragmatic excursion (ED)

    Secondary Outcome Measures

    1. Inter-observer reproductibility of the measurement of ED and EIT [Day 0]

      Comparison of the measure in the between two operators

    2. Predictive value of the presence of diaphragmatic dysfunction [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 [up to 7 days]

      length of hospitalization duration in Intensive care unit

    4. Predictive value of the presence of a diaphragmatic dysfunction on mortality [up to 7 days]

      Ultrasound measurement of diaphragmatic excursion (ED)

    5. Predictive value of the presence of a diaphragmatic dysfunction on mortality [6 months after the end of hospitalization]

      Ultrasound measurement of diaphragmatic excursion (ED)

    6. Kinetics of evolution of the diaphragmatic function [Day 1]

      Ultrasound measurement of diaphragmatic excursion (ED)

    7. Kinetics of evolution of the diaphragmatic function [Day 3]

      Ultrasound measurement of diaphragmatic excursion (ED)

    8. Evolution of the diaphragmatic function [Day 7]

      Ultrasound measurement of diaphragmatic excursion (ED)

    9. Evolution of the diaphragmatic function [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) [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 [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 [up to 7 days]

      scores ADL et AGGIR

    13. Presence of diaphragmatic dysfunction in patients with COVID-19 [up to 7 days]

      Ultrasound measurement of diaphragmatic excursion (ED)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire de la Réunion Saint-Denis France 97400

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de la Réunion

    Investigators

    • Principal Investigator: Thomas GROSEIL, Dr, CHU de La Réunion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de la Réunion
    ClinicalTrials.gov Identifier:
    NCT04520815
    Other Study ID Numbers:
    • 2020/CHU/10
    First Posted:
    Aug 20, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021