Weaning FailureNCT01928277
Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing
An observational study of Weaning Failure, run by University of Tromso at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure
- How many people
- 100 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU-patients weaning from mechanical ventilation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Levanger Hospital
Levanger, Levanger, 7600
St.Olav Hospital
Trondheim, Trondheim, 7000
About this study
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.
Read the 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.
- Conditions
- Weaning Failure
- Keywords
- Symptom assessment agreement, Work of breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU-patients | ICU-patients weaning form mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (2)
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
Measured: 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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- Nord-Trøndelag University College, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Sissel L Storli, PhD, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928277
- Sponsor's protocol ID
- 2012/1230(REK)
- Status last verified
- Dec 2014
- First submitted
- 28 Jun 2013
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26669474
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation: Spontaneous Breathing Trial and the Assessment of Work of Breathing
- ClinicalTrials.gov ID
- NCT01928277
- Acronym / sponsor ID
- 2012/1230(REK)
- Conditions
- Weaning Failure
- Keywords
- Symptom assessment agreement, Work of breathing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- Nord-Trøndelag University College, Helse Nord-Trøndelag HF
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU-patients | – | –ICU-patients weaning form mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU-patients weaning from mechanical ventilation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
The extent of agreement between patient and provider assessment of sense of security
Time frame: 30 minutes
The extent of agreement between patient and provider assessment of sense of breathing progress
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Derived from this study: PubMed 26669474Haugdahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sissel L Storli, PhD principal investigator
University of Tromso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Failure, run by University of Tromso at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The extent of agreement between patient and provider assessment of work of breathing (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01928277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.