Respiratory FailureNCT03894293
Correlations Among Functional Performance, Muscle Strength and Weaning Rate in Mechanically Ventilated Patients
An observational study of Respiratory Failure and Functional Performance, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Respiratory Failure, Functional Performance, Physical Therapy
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2019to 19 Feb 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Respiratory failure with mechanical ventilator user
Who may be able to join
- respiratory failure with mechanical ventilator use
- 48 hours after transferring to respiratory care center
- consciousness clear and can obey orders
- vital signs stable
Who cannot join
- conscious disturbance
- neuromuscular disease
- stroke
- fracture
- patho fracture
- BMI>45
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Wan-Ting Chu, master
About this study
To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate.
Read the detailed description
To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate. Investigators use the DEMMI and FSS-ICU to evaluation the physical functional performance. And MRC score and hand dynamometer to record the muscle strength. The weaning parameters include Pi, PE, RSI,minute ventilation, tidal volume and cuff leak will be recorded. After the participant enters the Respiration Care Center, Doctor and physical therapist evaluate the consciousness and meet the inclusion criteria and the participant will received the first evaluation. The second evaluation will be held before the ventilator weaning timing.
- Keywords
- functional performance, respiratory failure, weaning, mechanical ventilator, physical therapy, cardiopulmonary physical therapy
- Medical subject headings
- Respiratory Insufficiency
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 |
|---|---|---|
| ventilator group | It's a observational study. Participants entry the Respiratory Care Center and are evaluated. If the participant meet the inclusion criteria, the first assessments will be collected. After the weaning training, the second assessment will be collected before the the endotracheal tube is removed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlations between the Change from Baseline 'de Morton Mobility Index (DEMMI)' to the timing before weaning and the ventilator days
Correlations between the Functional physical performance and the ventilator days.It contains 5 items including bed skill, chair skills, static balance, walking and dynamic balance. The scores of 'bed', 'chair', 'static balance', 'walking' range from 0 to 4. And the score of 'dynamic balance' range from o to 3. The sum of 5 items is total raw score. Total Raw score is 0 to 19. And raw score can be converted to DEMMI score, ranging from 0 to 100. Higher values represent better mobility performance.
Measured: from baselineto the timing before weaning
Correlations between the Change from Baseline 'Functional Status Score for the ICU (FSS-ICU)' to the timing before weaning and the ventilator days
Correlations between the Functional physical performance and the ventilator days.It contains 5 items including rolling, supine-to-sit, unsupported sit, sit-to-stand and ambulation. The scores of 5 items range from 0 to 7. 0 means unable to perform; 1 means total assistance; 2 means maximum assistance; 3 means moderate assistance; 4means minimal assistance; 5 means supervision; 6 means moderate independence and 7 means complete independence. The total score ranges from 0 to 35. Higher values represent better functional performance.
Measured: from baselineto the timing before weaning
Secondary outcomes (4)
Correlations between the Change from Baseline 'grip - hand strength' to the timing before weaning and ventilator days
Correlations between the hand strength and ventilator days. The measurement unit is kilogram(kg). The measurement tool is Jamar® Plus+ Digital Hand Dynamometer. Participant is required to use the best effort to squeeze 15 seconds and repeat 3 times. Resting time is 30 seconds. Investigators record the data and calculate the average data.
Measured: from baselineto the timing before weaning
Correlation between the Change from Baseline 'Medical Research Council (MRC) scale' to the timing before weaning and ventilator days
Muscle strength assessment. 'Medical Research Council (MRC) scale' is an assessment tool of limb muscle strength. Left and Right sides are all tested. The Upper limb muscle tests include 'shoulder abduction', 'elbow flexion' and 'wrist extension. The lower limb muscle tests include 'hip flexion', 'knee extension' and 'ankle dorsiflexion'. The grades range from 0 to 5. Grade 0 means 'no contraction visible or palpable'; Grade 1 means 'flick of contraction visible or palpable, although no limb movement'; Grade3 means 'movement with gravity eliminated over almost full range of motion'; Grade 4 means 'movement against moderate resistance over full range of motion'; Grade 5 means 'normal power'. The sum of 6 items are total strength score which ranges from 0 to 60. Higher value represents better muscle strength. If the sum is below 48 points, it represents critical illness.
Measured: baseline, before weaning
Correlations between the Change from Baseline 'Maximal inspiration pressure(PI)' to the timing before weaning and ventilator days
Evaluate the inspiratory muscle strength.Instruct the participants exhale slowly and completely, and then try to breath in as hard as possible. The participants should maintain inspiratory pressure for at least 1.5 seconds and the largest negative pressure sustained for at least one second should be recorded. The unit is cm H2O. Higher value represent better inspiratory muscle strength.
Measured: from baselineto the timing before weaning
Correlation between the Change from Baseline 'Maximal expiration pressure(PE)' to the timing before weaning and ventilator days
Evaluate the inspiratory muscle strength.Instruct the participants inhale slowly and completely, and then try to breath out as hard as possible. The participants should maintain expiratory pressure for at least 1.5 seconds and the largest positive pressure sustained for at least one second should be recorded. The unit is cm H2O. Higher value represent better expiratory muscle strength.
Measured: from baselineto the timing before weaning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start20 Feb 2019
- Primary completion19 Feb 2020 (estimated)
- Study completion19 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894293
- Sponsor's protocol ID
- 2019-02-006C
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Connor ED, Walsham J. Should we mobilise critically ill patients? A review. Crit Care Resusc. 2009 Dec;11(4):290-300.
PubMed 20001881Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
PubMed 18596631Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Among Functional Performance, Muscle Strength and Weaning Rate in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03894293
- Acronym / sponsor ID
- 2019-02-006C
- Keywords
- functional performance, respiratory failure, weaning, mechanical ventilator, physical therapy, cardiopulmonary physical therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 19 Feb 2020 (estimated)
- Study completion
- 19 Feb 2020 (estimated)
- First posted
- 28 Mar 2019 (actual)
- 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.
To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate.
Detailed description
To assess the correlations among the physical functional performance, muscle strength, respiratory muscle strength and the ventilator weaning rate. Investigators use the DEMMI and FSS-ICU to evaluation the physical functional performance. And MRC score and hand dynamometer to record the muscle strength. The weaning parameters include Pi, PE, RSI,minute ventilation, tidal volume and cuff leak will be recorded. After the participant enters the Respiration Care Center, Doctor and physical therapist evaluate the consciousness and meet the inclusion criteria and the participant will received the first evaluation. The second evaluation will be held before the ventilator weaning timing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilator group | – | –It's a observational study. Participants entry the Respiratory Care Center and are evaluated. If the participant meet the inclusion criteria, the first assessments will be collected. After the weaning training, the second assessment will be collected before the the endotracheal tube is removed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Respiratory failure with mechanical ventilator user
Key inclusion criteria (4 listed)
- respiratory failure with mechanical ventilator use
- 48 hours after transferring to respiratory care center
- consciousness clear and can obey orders
- vital signs stable
Key exclusion criteria (6 listed)
- conscious disturbance
- neuromuscular disease
- stroke
- fracture
- patho fracture
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
correlations between the Change from Baseline 'de Morton Mobility Index (DEMMI)' to the timing before weaning and the ventilator days
Time frame: from baselineto the timing before weaning
Correlations between the Functional physical performance and the ventilator days.It contains 5 items including bed skill, chair skills, static balance, walking and dynamic balance. The scores of 'bed', 'chair', 'static balance', 'walking' range from 0 to 4. And the score of 'dynamic balance' range from o to 3. The sum of 5 items is total raw score. Total Raw score is 0 to 19. And raw score can be converted to DEMMI score, ranging from 0 to 100. Higher values represent better mobility performance.
Correlations between the Change from Baseline 'Functional Status Score for the ICU (FSS-ICU)' to the timing before weaning and the ventilator days
Time frame: from baselineto the timing before weaning
Correlations between the Functional physical performance and the ventilator days.It contains 5 items including rolling, supine-to-sit, unsupported sit, sit-to-stand and ambulation. The scores of 5 items range from 0 to 7. 0 means unable to perform; 1 means total assistance; 2 means maximum assistance; 3 means moderate assistance; 4means minimal assistance; 5 means supervision; 6 means moderate independence and 7 means complete independence. The total score ranges from 0 to 35. Higher values represent better functional performance.
4 secondary outcomes
Correlations between the Change from Baseline 'grip - hand strength' to the timing before weaning and ventilator days
Time frame: from baselineto the timing before weaning
Correlation between the Change from Baseline 'Medical Research Council (MRC) scale' to the timing before weaning and ventilator days
Time frame: baseline, before weaning
Correlations between the Change from Baseline 'Maximal inspiration pressure(PI)' to the timing before weaning and ventilator days
Time frame: from baselineto the timing before weaning
Correlation between the Change from Baseline 'Maximal expiration pressure(PE)' to the timing before weaning and ventilator days
Time frame: from baselineto the timing before weaning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Background: PubMed 20001881O'Connor ED, Walsham J. Should we mobilise critically ill patients? A review. Crit Care Resusc. 2009 Dec;11(4):290-300.
- Results publication: PubMed 18596631Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
- Results publication: PubMed 18511703Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Functional Performance, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Ting Chu, master (+886-28712121 ext. 2936, beryltipun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlations between the Change from Baseline 'de Morton Mobility Index (DEMMI)' to the timing before weaning and the ventilator days (time frame: from baselineto the timing before weaning). The study lists 2 primary outcomes in all. 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 NCT03894293, which also lists 3 linked publications.
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 28 Mar 2019.