NCT02636660

Brief Summary

This study will allow us to determine the perceived Health-Related Quality of Life (HRQL) a year after ICU discharge, and compare it with HRQL measured earlier on in the process, as well as analyse the negative experiences they had while in the ICU and as a result of MV and their impact over time. It will also allow us to assess the effect of Nursing Sensitive Outcomes and ICU stressors on health-related outcomes and how they affect HRQL.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

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

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

November 12, 2015

Last Update Submit

December 17, 2015

Conditions

Quality of Life

Keywords

Critical careMechanical VentilationQuality of LifeStressorsNursing Sensitive OutcomesNursing

Outcome Measures

Primary Outcomes (2)

  • Health-Related Quality of Life (HRQL) of patients admitted to ICU

    2 weeks after discharge from ICU

  • Health-Related Quality of Life (HRQL) of patients admitted to ICU

    1 year after discharge for ICU

Secondary Outcomes (9)

  • Differences in HRQL in mechanically ventilated patients prior to admission into ICU and one year after discharge from the ICU

    1 year after discharge for ICU

  • Relationship between the duration (in days) of mechanical ventilation and HRQL one year after discharge from the ICU

    1 year after discharge for ICU

  • Relationship between Nursing Sensitive Outcome 1 (Pressure Ulcer Care) and the HRQL of mechanically ventilated patients in ICU.

    1 year after discharge for ICU

  • Relationship between Nursing Sensitive Outcome 2 (Falls Prevention) and the HRQL of mechanically ventilated patients in ICU.

    1 year after discharge for ICU

  • Relationship between Nursing Sensitive Outcome 3 (Infection Control) and the HRQL of mechanically ventilated patients in ICU.

    1 year after discharge for ICU

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All mechanically ventilated patients admitted to our intensive care unit that fulfill the inclusion criteria.

You may qualify if:

  • Over 18 years old.
  • Mechanical ventilation for more than 48 hours.
  • Voluntary participation (signed informed consent).

You may not qualify if:

  • Patients admitted from other ICUs that had been mechanically ventilated for more than 48 hours at the time of admission to our centre.
  • Patients with domiciliary respiratory support.
  • Mentally or psychologically impaired patients (unable to comprehend the questionnaire).
  • Patients who do not speak Spanish fluently.
  • Patient without a permanent address (unable to do a proper follow-up).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • Frutos F, Allía I, Lorenzo MR, García PArdo J, Nolla M et al. Utilización de la ventilación mecánica en 72 unidades de cuidados intensivos en España. Medicina Intensiva 2003;27(1):1-12.

    RESULT

  • Esteban A, Anzueto A, Frutos F, Alia I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguia C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55. doi: 10.1001/jama.287.3.345.

    PMID: 11790214RESULT

  • Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.

    PMID: 16783553RESULT

  • Combes A, Costa MA, Trouillet JL, Baudot J, Mokhtari M, Gibert C, Chastre J. Morbidity, mortality, and quality-of-life outcomes of patients requiring >or=14 days of mechanical ventilation. Crit Care Med. 2003 May;31(5):1373-81. doi: 10.1097/01.CCM.0000065188.87029.C3.

    PMID: 12771605RESULT

  • Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

    PMID: 12594312RESULT

  • Schwartzmann L. Calidad de vida relacionada con la salud: aspectos conceptuales. Ciencia y enfermería 2003;IX(2):9-21.

    RESULT

  • Chatila W, Kreimer DT, Criner GJ. Quality of life in survivors of prolonged mechanical ventilatory support. Crit Care Med. 2001 Apr;29(4):737-42. doi: 10.1097/00003246-200104000-00007.

    PMID: 11373458RESULT

  • Chelluri L, Im KA, Belle SH, Schulz R, Rotondi AJ, Donahoe MP, Sirio CA, Mendelsohn AB, Pinsky MR. Long-term mortality and quality of life after prolonged mechanical ventilation. Crit Care Med. 2004 Jan;32(1):61-9. doi: 10.1097/01.CCM.0000098029.65347.F9.

    PMID: 14707560RESULT

  • McKinley S, Fien M, Elliott R, Elliott D. Health-Related Quality of Life and Associated Factors in Intensive Care Unit Survivors 6 Months After Discharge. Am J Crit Care. 2016 Jan;25(1):52-8. doi: 10.4037/ajcc2016995.

    PMID: 26724295RESULT

  • Douglas SL, Daly BJ, Gordon N, Brennan PF. Survival and quality of life: short-term versus long-term ventilator patients. Crit Care Med. 2002 Dec;30(12):2655-62. doi: 10.1097/00003246-200212000-00008.

    PMID: 12483055RESULT

  • Novaes MA, Knobel E, Bork AM, Pavao OF, Nogueira-Martins LA, Ferraz MB. Stressors in ICU: perception of the patient, relatives and health care team. Intensive Care Med. 1999 Dec;25(12):1421-6. doi: 10.1007/s001340051091.

    PMID: 10660851RESULT

  • Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A; JMIP Study Group. Patients' recollections of experiences in the intensive care unit may affect their quality of life. Crit Care. 2005 Apr;9(2):R96-109. doi: 10.1186/cc3026. Epub 2005 Jan 31.

    PMID: 15774056RESULT

  • Roberts BL, Rickard CM, Rajbhandari D, Reynolds P. Factual memories of ICU: recall at two years post-discharge and comparison with delirium status during ICU admission--a multicentre cohort study. J Clin Nurs. 2007 Sep;16(9):1669-77. doi: 10.1111/j.1365-2702.2006.01588.x.

    PMID: 17727586RESULT

  • Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52. doi: 10.1097/00003246-200204000-00004.

    PMID: 11940739RESULT

  • Samuelson KA. Unpleasant and pleasant memories of intensive care in adult mechanically ventilated patients--findings from 250 interviews. Intensive Crit Care Nurs. 2011 Apr;27(2):76-84. doi: 10.1016/j.iccn.2011.01.003. Epub 2011 Mar 2.

    PMID: 21371888RESULT

  • Tembo A, Parker V, Higgins I. The lived experience of critically ill patients in intensive care - A phenomenological inquiry. Australian Critical Care 2013;26(2):82.

    RESULT

  • Mendelsohn AB, Chelluri L. Interviews with intensive care unit survivors: assessing post-intensive care quality of life and patients' preferences regarding intensive care and mechanical ventilation. Crit Care Med. 2003 May;31(5 Suppl):S400-6. doi: 10.1097/01.CCM.0000065278.90460.F0. No abstract available.

    PMID: 12771591RESULT

  • Tsay SF, Mu PF, Lin S, Wang KW, Chen YC. The experiences of adult ventilator-dependent patients: a meta-synthesis review. Nurs Health Sci. 2013 Dec;15(4):525-33. doi: 10.1111/nhs.12049. Epub 2013 Mar 11.

    PMID: 23480454RESULT

  • Azoulay E, Kentish-Barnes N, Pochard F. Health-related quality of life: an outcome variable in critical care survivors. Chest. 2008 Feb;133(2):339-41. doi: 10.1378/chest.07-2547. No abstract available.

    PMID: 18252911RESULT

  • Riera A, Gallart E, Vicalvaro A, Lolo M, Solsona A, Mont A, Gomez J, Tellez D, Fuentelsaz-Gallego C. Health-related quality of life and nursing-sensitive outcomes in mechanically ventilated patients in an Intensive Care Unit: a study protocol. BMC Nurs. 2016 Feb 5;15:8. doi: 10.1186/s12912-016-0127-9. eCollection 2016.

    PMID: 26855613DERIVED

Study Officials

  • Maria Alba Riera Badia

    Nursing Supervisor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 12, 2015

First Posted

December 22, 2015

Study Start

June 1, 2012

Primary Completion

September 1, 2013

Study Completion

December 1, 2014

Last Updated

December 22, 2015

Record last verified: 2015-12