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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

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.

Conditions

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Weaning Failure

Keywords

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Symptom assessment agreement Work of breathing

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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ICU-patients

ICU-patients weaning form mechanical ventilation

No interventions assigned to this group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sissel L Storli, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tromso

Locations

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Levanger Hospital

Levanger, Levanger, Norway

Site Status

St.Olav Hospital

Trondheim, Trondheim, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED

PMID: 26669474 (View on PubMed)

Other Identifiers

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2012/1230(REK)

Identifier Type: -

Identifier Source: org_study_id