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

Weaning Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928277
• Other study ID #: 2012/1230(REK)
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: December 11, 2014
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Aspiration
• Weaning Failure

Locations

Country	Name	City	State
Norway	Levanger Hospital	Levanger
Norway	St.Olav Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
University of Tromso	Levanger Hospital, Nord-Trøndelag University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No