NCT02336464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
624

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 24, 2021

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

January 8, 2015

Last Update Submit

March 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • ICU length of stay

    3 months

  • incidence of post traumatic stress disorders

    3 months

Secondary Outcomes (4)

  • Anxiety and depression (Hamilton anxiety and depression scale)

    3 months

  • Quality of life (Short-Form 36)

    3 months

  • Pain (Visual Analogic Scale)

    3 months

  • Quality of Sleep (Pittsburgh Scale)

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié Salpetriere

Paris, 75013, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alesxandre Demoule, MD, PHD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

January 1, 2016

Primary Completion

April 13, 2018

Study Completion

June 1, 2018

Last Updated

March 24, 2021

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations