Clinical trial NCT02336464: Impact of Dyspnea on Patients in the Intensive Care Unit
Official title: Impact of DYSpnea on the ouTcome of Patients Admitted for an Acute RESpiratory Failure in the intenSive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aims of the present multicentre study are 1) to quantify the prevalence of dyspnea in a large population of ICU mechanically ventilated patients, 2) to examine the link between the level of dyspnea and the occurrence of adverse events in the ICU, 3) to determine whether dyspnea in intensive care unit patients is associated with a higher length of stay in the ICU and a higher incidence of post traumatic stress disorder associated symptoms.

Brief summary: Although pain has been extensively studied in ICU patients, only a few studies have focused on dyspnea, which is experienced by 50% of mechanically ventilated patients. The purpose of the present study is to determine whether dyspnea in intensive care unit patients is associated with a higher length of stay in the ICU and a higher incidence of post traumatic stress disorders.

Detailed description: Intensive care unit (ICU) patients are continuously exposed to various unpleasant sensations that are as many sources of discomfort. If, growing attention has been given to the detection and treatment of pain, very little attention has been given to dyspnea. However, there is growing evidence suggesting that dyspnea is frequent and severe in mechanically ventilated ICU patients. In mechanically ventilated ICU patients, dyspnea is independently associated with anxiety and mechanical ventilation itself. Indeed, an optimization of ventilator settings alleviates dyspnea in 35% of patients.

Various arguments suggest that dyspnea contributes to the dark experience of ICU and participates to the genesis of post traumatic stress disorders. In addition, dyspnea is associated with a longer duration of mechanical ventilation.

Large multicentre studies are however lacking. The aims of the present multicentre study are 1) to quantify the prevalence of dyspnea in a large population of ICU mechanically ventilated patients, 2) to examine the link between the level of dyspnea and the occurrence of adverse events in the ICU, 3) to determine whether dyspnea in intensive care unit patients is associated with a higher length of stay in the ICU and a higher incidence of post traumatic stress disorder associated symptoms.

Eligibility criteria: Inclusion criteria:

* Invasive mechanical ventilation in the ICU for \> 24 hours
* Remaining stay in the ICU estimated \> 24 hours

Exclusion criteria :

* RASS \<-2 or \>+2
* Delirium (defined according to CAM-ICU)
* Severe cognitive impairment or severe psychiatric disease
* Patient who does not understand French
* Severe depthless
* Age \<18 years

Primary outcomes:
measure: ICU length of stay
timeFrame: 3 months
measure: incidence of post traumatic stress disorders
timeFrame: 3 months
Secondary outcomes:
measure: Anxiety and depression (Hamilton anxiety and depression scale)
timeFrame: 3 months
measure: Quality of life (Short-Form 36)
timeFrame: 3 months
measure: Pain (Visual Analogic Scale)
timeFrame: 3 months
measure: Quality of Sleep (Pittsburgh Scale)
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpetriere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alesxandre Demoule, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demoule A, Hajage D, Messika J, Jaber S, Diallo H, Coutrot M, Kouatchet A, Azoulay E, Fartoukh M, Hraiech S, Beuret P, Darmon M, Decavele M, Ricard JD, Chanques G, Mercat A, Schmidt M, Similowski T; REVA Network (Research Network in Mechanical Ventilation). Prevalence, Intensity, and Clinical Impact of Dyspnea in Critically Ill Patients Receiving Invasive Ventilation. Am J Respir Crit Care Med. 2022 Apr 15;205(8):917-926. doi: 10.1164/rccm.202108-1857OC.