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

Respiratory Distress Syndrome, Adult Clinical Trial

— OLDIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520815
• Other study ID #: 2020/CHU/10
• Status: Recruiting
• Start date: June 24, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Emilie TECHER
• Phone: +2 62 262 90 62 89
• Email: emilie.techer[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de la Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of diaphragmatic dysfunction	Ultrasound measurement of diaphragmatic excursion (ED)	inclusion
Primary	Presence of diaphragmatic dysfunction	Ultrasound measurement of diaphragmatic excursion (ED)	Day 1
Primary	Presence of diaphragmatic dysfunction	Ultrasound measurement of diaphragmatic excursion (ED)	Day 3
Primary	Presence of diaphragmatic dysfunction	Ultrasound measurement of diaphragmatic excursion (ED)	Day 7
Primary	Presence of diaphragmatic dysfunction	Ultrasound measurement of diaphragmatic excursion (ED)	up to 7 days
Secondary	Inter-observer reproductibility of the measurement of ED and EIT	Comparison of the measure in the between two operators	Day 0
Secondary	Predictive value of the presence of diaphragmatic dysfunction	Ultrasound measurement of diaphragmatic excursion (ED) on the use of ventilatory assistance	48 hours after the beginning of hospitalization
Secondary	Predictive value of the presence of diaphragmatic dysfunction over the average length of hospital stay	length of hospitalization duration in Intensive care unit	up to 7 days
Secondary	Predictive value of the presence of a diaphragmatic dysfunction on mortality	Ultrasound measurement of diaphragmatic excursion (ED)	up to 7 days
Secondary	Predictive value of the presence of a diaphragmatic dysfunction on mortality	Ultrasound measurement of diaphragmatic excursion (ED)	6 months after the end of hospitalization
Secondary	Kinetics of evolution of the diaphragmatic function	Ultrasound measurement of diaphragmatic excursion (ED)	Day 1
Secondary	Kinetics of evolution of the diaphragmatic function	Ultrasound measurement of diaphragmatic excursion (ED)	Day 3
Secondary	Evolution of the diaphragmatic function	Ultrasound measurement of diaphragmatic excursion (ED)	Day 7
Secondary	Evolution of the diaphragmatic function	Ultrasound measurement of diaphragmatic excursion (ED)	Before 7 days
Secondary	Correlation between risk factors for developing diaphragmatic dysfunction (DD) and ultrasound diagnosis of diaphragmatic dysfunction (DD)	Identification of the risk factors and Ultrasound measurement of diaphragmatic excursion (ED)	up to 7 days
Secondary	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	qSOFA et APACHE II score	up to 7 days
Secondary	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	scores ADL et AGGIR	up to 7 days
Secondary	Presence of diaphragmatic dysfunction in patients with COVID-19	Ultrasound measurement of diaphragmatic excursion (ED)	up to 7 days