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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01928277
Enrollment
100
Registered
2013-08-23
Start date
2012-09-30
Completion date
2014-12-31
Last updated
2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weaning Failure

Keywords

Symptom assessment agreement, Work of breathing

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.

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.

Interventions

None listed

Sponsors

Nord-Trøndelag University College
CollaboratorOTHER
Helse Nord-Trøndelag HF
CollaboratorOTHER
University of Tromso
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The extent of agreement between patient and provider assessment of work of breathing30 minutes30 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

MeasureTime frameDescription
The extent of agreement between patient and provider assessment of sense of security30 minutes30 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
The extent of agreement between patient and provider assessment of sense of breathing progress30 minutes30 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

MeasureTime frame
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026