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

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.

Study Overview

• Status: Completed
• Conditions: Weaning Failure

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Norway
  • Levanger, Norway, 7600
    • Levanger Hospital
  • Trondheim, Norway, 7000
    • St.Olav Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU-patients weaning from mechanical ventilation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICU-patients; ICU-patients weaning form mechanical ventilation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: University of Tromso
• Collaborators: Helse Nord-Trøndelag HF; Nord-Trøndelag University College
• Investigators: Principal Investigator: Sissel L Storli, PhD, University of Tromso

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Work of breathing; Symptom assessment agreement
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2012/1230(REK)