Impact of Dyspnea on Patients in the Intensive Care Unit

Dyspnea Clinical Trial

— DYSTRESS  

Official title:

Impact of DYSpnea on the ouTcome of Patients Admitted for an Acute RESpiratory Failure in the intenSive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336464
• Other study ID #: K120103
• Status: Completed
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: June 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU length of stay		3 months
Primary	incidence of post traumatic stress disorders		3 months
Secondary	Anxiety and depression (Hamilton anxiety and depression scale)	Hamilton anxiety and depression scale	3 months
Secondary	Quality of life (Short-Form 36)	Short-Form 36	3 months
Secondary	Pain (Visual Analogic Scale)	Visual Analogic Scale	3 months
Secondary	Quality of Sleep (Pittsburgh Scale)	Pittsburgh Scale	3 months