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Completed

NCT Number: NCT01928277

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Levanger Hospital, Levanger, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The extent of agreement between patient and provider assessment of work of breathing

    Time frame: 30 minutes

    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

Secondary outcomes

  1. The extent of agreement between patient and provider assessment of sense of security

    Time frame: 30 minutes

    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

  2. The extent of agreement between patient and provider assessment of sense of breathing progress

    Time frame: 30 minutes

    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

Other outcomes

  1. Association of agreement of work of breathing with demographic- and disease-related factor (Age, gender, SOFA-score, ventilator time, ICU-mortality)

    Time frame: within the first 30 days

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • Helse Nord-Trøndelag HF
  • Nord-Trøndelag University College

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2013
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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