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Clinical Trials/NCT04520815
NCT04520815
Unknown
N/A

Assessment of the Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress

Centre Hospitalier Universitaire de la Réunion1 site in 1 country100 target enrollmentJune 24, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Adult
Sponsor
Centre Hospitalier Universitaire de la Réunion
Enrollment
100
Locations
1
Primary Endpoint
Presence of diaphragmatic dysfunction
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2020
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Responsible Party
Sponsor

Eligibility 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.
  • 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.

Outcomes

Primary Outcomes

Presence of diaphragmatic dysfunction

Time Frame: up to 7 days

Ultrasound measurement of diaphragmatic excursion (ED)

Secondary Outcomes

  • Correlation between risk factors for developing diaphragmatic dysfunction (DD) and ultrasound diagnosis of diaphragmatic dysfunction (DD)(up to 7 days)
  • Evolution of the diaphragmatic function(Before 7 days)
  • Inter-observer reproductibility of the measurement of ED and EIT(Day 0)
  • 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)
  • Predictive value of the presence of diaphragmatic dysfunction over the average length of hospital stay(up to 7 days)
  • Kinetics of evolution of the diaphragmatic function(Day 3)
  • Predictive value of the presence of diaphragmatic dysfunction(48 hours after the beginning of hospitalization)
  • Predictive value of the presence of a diaphragmatic dysfunction on mortality(6 months after the end of hospitalization)
  • 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)
  • Presence of diaphragmatic dysfunction in patients with COVID-19(up to 7 days)

Study Sites (1)

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