Clinical trial NCT04520815: Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress
Official title: Assessment of the Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


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 \<7.35.
* 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.

Primary outcomes:
measure: Presence of diaphragmatic dysfunction
timeFrame: inclusion
measure: Presence of diaphragmatic dysfunction
timeFrame: Day 1
measure: Presence of diaphragmatic dysfunction
timeFrame: Day 3
measure: Presence of diaphragmatic dysfunction
timeFrame: Day 7
measure: Presence of diaphragmatic dysfunction
timeFrame: up to 7 days
Secondary outcomes:
measure: Inter-observer reproductibility of the measurement of ED and EIT
timeFrame: Day 0
measure: Predictive value of the presence of diaphragmatic dysfunction
timeFrame: 48 hours after the beginning of hospitalization
measure: Predictive value of the presence of diaphragmatic dysfunction over the average length of hospital stay
timeFrame: up to 7 days
measure: Predictive value of the presence of a diaphragmatic dysfunction on mortality
timeFrame: up to 7 days
measure: Predictive value of the presence of a diaphragmatic dysfunction on mortality
timeFrame: 6 months after the end of hospitalization
measure: Kinetics of evolution of the diaphragmatic function
timeFrame: Day 1
measure: Kinetics of evolution of the diaphragmatic function
timeFrame: Day 3
measure: Evolution of the diaphragmatic function
timeFrame: Day 7
measure: Evolution of the diaphragmatic function
timeFrame: Before 7 days
measure: Correlation between risk factors for developing diaphragmatic dysfunction (DD) and ultrasound diagnosis of diaphragmatic dysfunction (DD)
timeFrame: up to 7 days
measure: 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
timeFrame: up to 7 days
measure: 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
timeFrame: up to 7 days
measure: Presence of diaphragmatic dysfunction in patients with COVID-19
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire de la Réunion
Study officials:
affiliation: CHU de La Réunion
name: Thomas GROSEIL, Dr
role: PRINCIPAL_INVESTIGATOR
References: