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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Weaning Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU-patients<br>ICU-patients weaning form mechanical ventilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of agreement between patient and provider assessment of sense of security | 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 | 30 minutes | 
| The extent of agreement between patient and provider assessment of sense of breathing progress | 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 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom assessment agreement, Work of breathing