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Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing

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ClinicalTrials.gov Identifier: NCT01928277
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : December 12, 2014
Sponsor:
Collaborators:
Nord-Trøndelag University College
Levanger Hospital
Information provided by (Responsible Party):
University of Tromso

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.

Condition or disease
Weaning Failure

Detailed Description:

Mechanical ventilation is among the most common interventions in the intensive care unit (ICU). Over the last two decades, numerous studies have investigated methods to improve outcomes of patients receiving mechanical ventilation. Despite this proliferation of data, a large, multi-national cohort study found clinical outcomes such as duration of ventilation and ICU stay have not improved significantly between1998 to 2004.

It is recommended that weaning should be considered as early as possible in the patient trajectory and spontaneous breathing trials (SBT) attempted, as SBT are the best diagnostic criteria to determine extubation readiness. The decision of ready to extubate is considered complex because both delayed and failed extubations are associated with increased ventilator time and increased mortality. It is shown that dyspnea occurs among nearly half of ventilator patients and is strongly associated with anxiety and delayed extubation. Between 30-75% of ICU patients report anxiety where dyspnea, impaired communication skills, and sleep disturbances may be predisposing factors. The assessments of work of breathing and clinical deterioration are important sub-categories in clinical judgment for determining weaning tolerance.

There is little evidence whether the patients experiences of work of breathing is correlating with physicians and nurses. Hence, we suggest the need to evaluate the interobserver agreement for clinical assessment in weaning.

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort
ICU-patients
ICU-patients weaning form mechanical ventilation



Primary Outcome Measures :
  1. The extent of agreement between patient and provider assessment of work of breathing [ Time Frame: 30 minutes ]
    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


Secondary Outcome Measures :
  1. The extent of agreement between patient and provider assessment of sense of security [ Time Frame: 30 minutes ]
    30 minutes after the initiating of SBT, the patient is asked to rate the sense of security on a numerous rating scale (NRS, 0-10) At the same time nurse and physician are asked to assess the patients sense of security on a NRS

  2. The extent of agreement between patient and provider assessment of sense of breathing progress [ Time Frame: 30 minutes ]
    30 minutes after the initiating of SBT, the patient is asked to rate the sense of breathing progress on a numerous rating scale (NRS, 0-10) At the same time nurse and physician are asked to assess the patients' breathing progress on a NRS


Other Outcome Measures:
  1. Association of agreement of work of breathing with demographic- and disease-related factor (Age, gender, SOFA-score, ventilator time, ICU-mortality) [ Time Frame: within the first 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU-patients weaning from mechanical ventilation
Criteria

Inclusion Criteria:

  • Patients using artificial airway (intubation and / or tracheostomy)
  • Duration of mechanical ventilation longer than 24 hours
  • weaning from mechanical ventilation
  • 18 years of age or older
  • Motor Activity Assessment Scale (MAAS) 3-4

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928277


Locations
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Norway
Levanger Hospital
Levanger, Norway, 7600
St.Olav Hospital
Trondheim, Norway, 7000
Sponsors and Collaborators
University of Tromso
Nord-Trøndelag University College
Levanger Hospital
Investigators
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Principal Investigator: Sissel L Storli, PhD University of Tromso
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01928277    
Other Study ID Numbers: 2012/1230(REK)
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Keywords provided by University of Tromso:
Symptom assessment agreement
Work of breathing
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes