Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing
1 other identifier
observational
100
1 country
2
Brief Summary
The main objective of the study is to examine the extent of agreement between patient and health care provider assessments of work of breathing and the association of agreement with demographic- and disease-related factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Typical duration for all trials
2 active sites
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
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2013
CompletedFirst Posted
Study publicly available on registry
August 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 12, 2014
December 1, 2014
2 years
June 28, 2013
December 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The extent of agreement between patient and provider assessment of work of breathing
30 minutes after the initiating of SBT, the patient is asked to rate the sense of work of breathing on a numerous rating scale (NRS, 0-10) At the same time nurse and physician are asked to assess the patients work of breathing on a NRS
30 minutes
Secondary Outcomes (2)
The extent of agreement between patient and provider assessment of sense of security
30 minutes
The extent of agreement between patient and provider assessment of sense of breathing progress
30 minutes
Other Outcomes (1)
Association of agreement of work of breathing with demographic- and disease-related factor (Age, gender, SOFA-score, ventilator time, ICU-mortality)
within the first 30 days
Study Arms (1)
ICU-patients
ICU-patients weaning form mechanical ventilation
Eligibility Criteria
ICU-patients weaning from mechanical ventilation
You may qualify if:
- Patients using artificial airway (intubation and / or tracheostomy)
- Duration of mechanical ventilation longer than 24 hours
- weaning from mechanical ventilation
- years of age or older
- Motor Activity Assessment Scale (MAAS) 3-4
You may not qualify if:
- less than 18 years of age
- insufficient command of the language spoken in the study center
- serious brain damage
- withdrawal of consent at any stage of the research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tromsolead
- Nord-Trøndelag University Collegecollaborator
- Helse Nord-Trøndelag HFcollaborator
Study Sites (2)
Levanger Hospital
Levanger, Levanger, 7600, Norway
St.Olav Hospital
Trondheim, Trondheim, 7000, Norway
Related Publications (1)
Haugdahl HS, Storli SL, Meland B, Dybwik K, Romild U, Klepstad P. Underestimation of Patient Breathlessness by Nurses and Physicians during a Spontaneous Breathing Trial. Am J Respir Crit Care Med. 2015 Dec 15;192(12):1440-8. doi: 10.1164/rccm.201503-0419OC.
PMID: 26669474DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sissel L Storli, PhD
University of Tromso
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2013
First Posted
August 23, 2013
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
December 12, 2014
Record last verified: 2014-12