Clinical trial NCT01928277: Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing
Official title: Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Failure
Keywords: Symptom assessment agreement
Work of breathing
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Nord-Trøndelag University College
name: Helse Nord-Trøndelag HF
First posted: 2013-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU-patients weaning from mechanical ventilation

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.

Eligibility 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

Primary outcomes:
measure: The extent of agreement between patient and provider assessment of work of breathing
timeFrame: 30 minutes
Secondary outcomes:
measure: The extent of agreement between patient and provider assessment of sense of security
timeFrame: 30 minutes
measure: The extent of agreement between patient and provider assessment of sense of breathing progress
timeFrame: 30 minutes
Other outcomes:
measure: Association of agreement of work of breathing with demographic- and disease-related factor (Age, gender, SOFA-score, ventilator time, ICU-mortality)
timeFrame: within the first 30 days
Locations:
city: Levanger
country: Norway
facility: Levanger Hospital
city: Trondheim
country: Norway
facility: St.Olav Hospital
Study officials:
affiliation: University of Tromso
name: Sissel L Storli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.