Impact of Dyspnea on Patients in the Intensive Care Unit

Completed

• Conditions: Dyspnea

• Registration Number: NCT02336464
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Study Start: 2016-01
• Primary Completion: 2018-04-13
• Status Verified: 2018-05
• Study Completion: 2018-06
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of post traumatic stress disorders	3 months
ICU length of stay	3 months

Secondary Outcome Measures

Name	Time	Method
Quality of Sleep (Pittsburgh Scale)	3 months	Pittsburgh Scale
Pain (Visual Analogic Scale)	3 months	Visual Analogic Scale
Anxiety and depression (Hamilton anxiety and depression scale)	3 months	Hamilton anxiety and depression scale
Quality of life (Short-Form 36)	3 months	Short-Form 36

Trial Locations

Locations (1)

Groupe Hospitalier Pitié Salpetriere; 🇫🇷 Paris, France