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Completed

NCT Number: NCT02336464

Impact of Dyspnea on Patients in the Intensive Care Unit

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pitié Salpetriere

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ICU length of stay

    Time frame: 3 months

  2. incidence of post traumatic stress disorders

    Time frame: 3 months

Secondary outcomes

  1. Anxiety and depression (Hamilton anxiety and depression scale)

    Time frame: 3 months

    Hamilton anxiety and depression scale

  2. Quality of life (Short-Form 36)

    Time frame: 3 months

    Short-Form 36

  3. Pain (Visual Analogic Scale)

    Time frame: 3 months

    Visual Analogic Scale

  4. Quality of Sleep (Pittsburgh Scale)

    Time frame: 3 months

    Pittsburgh Scale

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: DYSTRESS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2015
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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