ICU Acquired WeaknessNCT04914065
Predictors of Prognosis in Patients With Critical Illness.
An observational study of ICU Acquired Weakness and Weaning Failure, run by Taoyuan General Hospital at 1 site in Taiwan.
Trial summary
Recently, intensive care unit acquired weakness (ICUAW) has become a hotspot issue in the patients with critical illness. The symptoms of ICUAW, including sensory impairment and muscle atrophy, may lead to poor quality of life even though the patients discharged from the ICU for a long time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ICU Acquired Weakness, Weaning Failure, Quality of Life
- What is being tested?
- Regular care in the surgery intensive care unit
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2020to 13 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU
Who may be able to join
- Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU
Who cannot join
- Hemodynamic instability patients, e.g., patients with ECMO
- Patients refuse to participate this study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
Taoyuan, 330
About this study
Recently, intensive care unit acquired weakness (ICUAW) has become a hotspot issue in the patients with critical illness. The symptoms of ICUAW, including sensory impairment and muscle atrophy, may lead to poor quality of life even though the patients discharged from the ICU for a long time. Therefore, an ounce of prevention is worth a pound of cure. At the same time, early evaluation is necessary to keep critically ill patients away from ICUAW. Medical Research Council (MRC) scale is the most common approach for diagnosis clinically. Regarding the interrater variation of MRC, handgrip strength (HGS) has been thought to be a simple and accurate alternative. However, HGS does not belong to antigravity or respiratory muscle which are the first to be affected by immobilization. It is still unknown whether HGS can represent the general muscle condition in ICU or not.
Additionally, previous studies have proved that patients with critical illness in the ICU would have better prognosis and less complications, if they undergo physical therapy as soon as possible. In addition to early ventilator weaning and reduced mortality rate, physical therapy could enhance quality of life (QoL) after patient discharges from hospital. However, early mobility in the ICU mainly emphasizes cardiopulmonary patients due to the traditional concept in Taiwan. Hence, the duration of mechanical ventilation in the critical patients will affect the timing to receive physical therapy, even impact the improvement of QoL.
Because of these reasons, this study will investigate the relationship between HGS and muscle mass among patients with critical illness and find the predictors of the short-term and long-term goals in the ICU, including ventilator weaning and QoL after hospital discharge.
Read the detailed description
This prospective and observational study will be divided into 2 parts: 1) The association between handgrip strength and muscle mass in intensive care unit patients. 2) Predictors of short-term and long-term goals in ICU.
Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours from admission to ICU. The outcome measures include HGS assessed by electronic hand dynamometer and muscle thickness of diaphragm and quadriceps detected by ultrasound.
The short-term goal is weaning ventilator, and the long-term goal is quality of life after discharge from hospital assessed through SF-36 Taiwan version. Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours after ICU admission. The collected data contain muscle strength, muscle mass, physical function, respiratory function, and observation of delirium or not. The evaluations of muscle strength include 3 parts which are limbs(handgrip), respiratory muscle(Maximal Inspiratory Pressure), and general muscle strength(Medical Research Council scale); Secondly, the evaluations of muscle mass divide 2 parts which are limbs(muscle thickness of quadriceps) and respiratory muscle(muscle thickness of diaphragm); Thirdly, the evaluations of physical function are 2 ways which are FSS-ICU and 2 mins walk test after discharge from the ICU; Fourthly, the evaluations of respiratory function contain 3 measurements of FEV1, FVC, and FEV1/FVC; Finally, the evaluation of delirium is assessed by CAM-ICU.
The statistical analysis will use SPSS version 24. Pearson correlation test will be conducted to investigate the association between HGS and muscle thickness. Multiple regression will be used to investigate the predictors for weaning ventilator successfully and quality of life after hospital discharge.
- Conditions
- ICU Acquired Weakness, Weaning Failure, Quality of Life
- Being tested
- Regular care in the surgery intensive care unit
- Keywords
- Intensive care unit acquired weakness, Handgrip strength, Muscle thickness, Predictor, Ventilator weaning, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular care in the surgery intensive care unitOther
Part 1: Two arms(muscle thickness observation):
- Inspiratory muscles: diaphragm
- Anti-gravity muscles: rectus femoris and the vastus intermedius
Part 2: Predictors of short-term and long-term goals in the ICU
- Short-term goal: successful ventilator weaning in the ICU- pass weaning profile without re-intubation in the hospital
- Long-term goal- Quality of life after hospital discharge: SF-36 (Taiwan version)
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge
Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
Measured: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
Part 1: Change of diaphragm thickness from ICU admission to ICU discharge
Muscle thickness of diaphragm and quadriceps detected by ultrasound(GE vivid S5)
Measured: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
Part 2: Change of Handgrip strength (HGS)
Change of Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
Measured: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Part 2: Change of General muscle strength
Change of General muscle strength- MRC scale
Measured: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Part 2: Change of Muscle mass
Muscle thickness of diaphragm and quadriceps detected by ultrasound (GE vivid S5)
Measured: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Part 2: Respiratory muscle strength
Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)
Measured: the day that patient received weaning profile tests during ICU
Part 2: Change of Physical function
Change of FSS-ICU
Measured: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Part 2: Physical function at ICU discharge
2 mins walk test
Measured: conducted at the day of ICU discharge
Part 2: Change of Delirium
CAM-ICU
Measured: conducted every day in the ICU
Part 2: Respiratory function
FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)
Measured: conducted at the day of ICU discharge
Part 2: Quality of life- SF-36(Taiwan version)
SF-36(Taiwan version)
Measured: conducted by phone call at discharge for 6 months from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Jan 2020
- Primary completion13 Jul 2021
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ICU Acquired WeaknessStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University, Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Sponsor
- Investigators
- Huan-Jui Yeh, Study chair, Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914065
- Sponsor's protocol ID
- TYGH108031
- Status last verified
- Jul 2021
- First submitted
- 25 May 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thille AW, Boissier F, Muller M, Levrat A, Bourdin G, Rosselli S, Frat JP, Coudroy R, Vivier E. Role of ICU-acquired weakness on extubation outcome among patients at high risk of reintubation. Crit Care. 2020 Mar 12;24(1):86. doi: 10.1186/s13054-020-2807-9.
PubMed 32164739Meyer-Friessem CH, Malewicz NM, Rath S, Ebel M, Kaisler M, Tegenthoff M, Schildhauer TA, Pogatzki-Zahn EM, Maier C, Zahn PK. Incidence, Time Course and Influence on Quality of Life of Intensive Care Unit-Acquired Weakness Symptoms in Long-Term Intensive Care Survivors. J Intensive Care Med. 2021 Nov;36(11):1313-1322. doi: 10.1177/0885066620949178. Epub 2020 Aug 17.
PubMed 32799703Cottereau G, Dres M, Avenel A, Fichet J, Jacobs FM, Prat D, Hamzaoui O, Richard C, Antonello M, Sztrymf B. Handgrip Strength Predicts Difficult Weaning But Not Extubation Failure in Mechanically Ventilated Subjects. Respir Care. 2015 Aug;60(8):1097-104. doi: 10.4187/respcare.03604. Epub 2015 Mar 10.
PubMed 25759461Kutchak FM, Rieder MM, Victorino JA, Meneguzzi C, Poersch K, Forgiarini LA Junior, Bianchin MM. Simple motor tasks independently predict extubation failure in critically ill neurological patients. J Bras Pneumol. 2017 May-Jun;43(3):183-189. doi: 10.1590/S1806-37562016000000155.
PubMed 28746528Saiphoklang N, Tepwimonpetkun C. Interest of hand grip strength to predict outcome in mechanically ventilated patients. Heart Lung. 2020 Sep-Oct;49(5):637-640. doi: 10.1016/j.hrtlng.2020.03.019. Epub 2020 May 6.
PubMed 32387152Braganca RD, Ravetti CG, Barreto L, Ataide TBLS, Carneiro RM, Teixeira AL, Nobre V. Use of handgrip dynamometry for diagnosis and prognosis assessment of intensive care unit acquired weakness: A prospective study. Heart Lung. 2019 Nov-Dec;48(6):532-537. doi: 10.1016/j.hrtlng.2019.07.001. Epub 2019 Jul 15.
PubMed 31320179Jolley SE, Bunnell AE, Hough CL. ICU-Acquired Weakness. Chest. 2016 Nov;150(5):1129-1140. doi: 10.1016/j.chest.2016.03.045. Epub 2016 Apr 7.
PubMed 27063347Sidiras G, Patsaki I, Karatzanos E, Dakoutrou M, Kouvarakos A, Mitsiou G, Routsi C, Stranjalis G, Nanas S, Gerovasili V. Long term follow-up of quality of life and functional ability in patients with ICU acquired Weakness - A post hoc analysis. J Crit Care. 2019 Oct;53:223-230. doi: 10.1016/j.jcrc.2019.06.022. Epub 2019 Jun 21.
PubMed 31277049Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.
PubMed 28887062Vanhorebeek I, Latronico N, Van den Berghe G. ICU-acquired weakness. Intensive Care Med. 2020 Apr;46(4):637-653. doi: 10.1007/s00134-020-05944-4. Epub 2020 Feb 19.
PubMed 32076765Bohannon RW, Wang YC, Gershon RC. Two-minute walk test performance by adults 18 to 85 years: normative values, reliability, and responsiveness. Arch Phys Med Rehabil. 2015 Mar;96(3):472-7. doi: 10.1016/j.apmr.2014.10.006. Epub 2014 Oct 25.
PubMed 25450135Fuke R, Hifumi T, Kondo Y, Hatakeyama J, Takei T, Yamakawa K, Inoue S, Nishida O. Early rehabilitation to prevent postintensive care syndrome in patients with critical illness: a systematic review and meta-analysis. BMJ Open. 2018 May 5;8(5):e019998. doi: 10.1136/bmjopen-2017-019998.
PubMed 29730622Zein H, Baratloo A, Negida A, Safari S. Ventilator Weaning and Spontaneous Breathing Trials; an Educational Review. Emerg (Tehran). 2016 Spring;4(2):65-71.
PubMed 27274515
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Prognosis in Patients With Critical Illness.
- ClinicalTrials.gov ID
- NCT04914065
- Acronym / sponsor ID
- TYGH108031
- Conditions
- ICU Acquired Weakness, Weaning Failure, Quality of Life
- Keywords
- Intensive care unit acquired weakness, Handgrip strength, Muscle thickness, Predictor, Ventilator weaning, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Taoyuan General HospitalOther government
- Collaborators
- National Yang Ming Chiao Tung University, Ministry of Science and Technology of the People´s Republic of China
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 4 Jun 2021 (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.
Recently, intensive care unit acquired weakness (ICUAW) has become a hotspot issue in the patients with critical illness. The symptoms of ICUAW, including sensory impairment and muscle atrophy, may lead to poor quality of life even though the patients discharged from the ICU for a long time. Therefore, an ounce of prevention is worth a pound of cure. At the same time, early evaluation is necessary to keep critically ill patients away from ICUAW. Medical Research Council (MRC) scale is the most common approach for diagnosis clinically. Regarding the interrater variation of MRC, handgrip strength (HGS) has been thought to be a simple and accurate alternative. However, HGS does not belong to antigravity or respiratory muscle which are the first to be affected by immobilization. It is still unknown whether HGS can represent the general muscle condition in ICU or not.
Additionally, previous studies have proved that patients with critical illness in the ICU would have better prognosis and less complications, if they undergo physical therapy as soon as possible. In addition to early ventilator weaning and reduced mortality rate, physical therapy could enhance quality of life (QoL) after patient discharges from hospital. However, early mobility in the ICU mainly emphasizes cardiopulmonary patients due to the traditional concept in Taiwan. Hence, the duration of mechanical ventilation in the critical patients will affect the timing to receive physical therapy, even impact the improvement of QoL.
Because of these reasons, this study will investigate the relationship between HGS and muscle mass among patients with critical illness and find the predictors of the short-term and long-term goals in the ICU, including ventilator weaning and QoL after hospital discharge.
Detailed description
This prospective and observational study will be divided into 2 parts: 1) The association between handgrip strength and muscle mass in intensive care unit patients. 2) Predictors of short-term and long-term goals in ICU.
Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours from admission to ICU. The outcome measures include HGS assessed by electronic hand dynamometer and muscle thickness of diaphragm and quadriceps detected by ultrasound.
The short-term goal is weaning ventilator, and the long-term goal is quality of life after discharge from hospital assessed through SF-36 Taiwan version. Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours after ICU admission. The collected data contain muscle strength, muscle mass, physical function, respiratory function, and observation of delirium or not. The evaluations of muscle strength include 3 parts which are limbs(handgrip), respiratory muscle(Maximal Inspiratory Pressure), and general muscle strength(Medical Research Council scale); Secondly, the evaluations of muscle mass divide 2 parts which are limbs(muscle thickness of quadriceps) and respiratory muscle(muscle thickness of diaphragm); Thirdly, the evaluations of physical function are 2 ways which are FSS-ICU and 2 mins walk test after discharge from the ICU; Fourthly, the evaluations of respiratory function contain 3 measurements of FEV1, FVC, and FEV1/FVC; Finally, the evaluation of delirium is assessed by CAM-ICU.
The statistical analysis will use SPSS version 24. Pearson correlation test will be conducted to investigate the association between HGS and muscle thickness. Multiple regression will be used to investigate the predictors for weaning ventilator successfully and quality of life after hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU
Key inclusion criteria (1 listed)
- Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU
Key exclusion criteria (2 listed)
- Hemodynamic instability patients, e.g., patients with ECMO
- Patients refuse to participate this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular care in the surgery intensive care unitPart 1: Two arms(muscle thickness observation): 1. Inspiratory muscles: diaphragm 2. Anti-gravity muscles: rectus femoris and the vastus intermedius Part 2: Predictors of short-term and long-term goals in the ICU 1. Short-term goal: successful ventilator weaning in the ICU- pass weaning profile without re-intubation in the hospital 2. Long-term goal- Quality of life after hospital discharge: SF-36 (Taiwan version) | Other | – |
Primary outcome
Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge
Time frame: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
Part 1: Change of diaphragm thickness from ICU admission to ICU discharge
Time frame: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
Muscle thickness of diaphragm and quadriceps detected by ultrasound(GE vivid S5)
Part 2: Change of Handgrip strength (HGS)
Time frame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Change of Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
Part 2: Change of General muscle strength
Time frame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Change of General muscle strength- MRC scale
Part 2: Change of Muscle mass
Time frame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Muscle thickness of diaphragm and quadriceps detected by ultrasound (GE vivid S5)
Part 2: Respiratory muscle strength
Time frame: the day that patient received weaning profile tests during ICU
Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)
Part 2: Change of Physical function
Time frame: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Change of FSS-ICU
Part 2: Physical function at ICU discharge
Time frame: conducted at the day of ICU discharge
2 mins walk test
Part 2: Change of Delirium
Time frame: conducted every day in the ICU
CAM-ICU
Part 2: Respiratory function
Time frame: conducted at the day of ICU discharge
FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)
Part 2: Quality of life- SF-36(Taiwan version)
Time frame: conducted by phone call at discharge for 6 months from ICU
SF-36(Taiwan version)
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 19 Jul 2021.
- Background: PubMed 32164739Thille AW, Boissier F, Muller M, Levrat A, Bourdin G, Rosselli S, Frat JP, Coudroy R, Vivier E. Role of ICU-acquired weakness on extubation outcome among patients at high risk of reintubation. Crit Care. 2020 Mar 12;24(1):86. doi: 10.1186/s13054-020-2807-9.
- Background: PubMed 32799703Meyer-Friessem CH, Malewicz NM, Rath S, Ebel M, Kaisler M, Tegenthoff M, Schildhauer TA, Pogatzki-Zahn EM, Maier C, Zahn PK. Incidence, Time Course and Influence on Quality of Life of Intensive Care Unit-Acquired Weakness Symptoms in Long-Term Intensive Care Survivors. J Intensive Care Med. 2021 Nov;36(11):1313-1322. doi: 10.1177/0885066620949178. Epub 2020 Aug 17.
- Background: PubMed 25759461Cottereau G, Dres M, Avenel A, Fichet J, Jacobs FM, Prat D, Hamzaoui O, Richard C, Antonello M, Sztrymf B. Handgrip Strength Predicts Difficult Weaning But Not Extubation Failure in Mechanically Ventilated Subjects. Respir Care. 2015 Aug;60(8):1097-104. doi: 10.4187/respcare.03604. Epub 2015 Mar 10.
- Background: PubMed 28746528Kutchak FM, Rieder MM, Victorino JA, Meneguzzi C, Poersch K, Forgiarini LA Junior, Bianchin MM. Simple motor tasks independently predict extubation failure in critically ill neurological patients. J Bras Pneumol. 2017 May-Jun;43(3):183-189. doi: 10.1590/S1806-37562016000000155.
- Background: PubMed 32387152Saiphoklang N, Tepwimonpetkun C. Interest of hand grip strength to predict outcome in mechanically ventilated patients. Heart Lung. 2020 Sep-Oct;49(5):637-640. doi: 10.1016/j.hrtlng.2020.03.019. Epub 2020 May 6.
- Background: PubMed 31320179Braganca RD, Ravetti CG, Barreto L, Ataide TBLS, Carneiro RM, Teixeira AL, Nobre V. Use of handgrip dynamometry for diagnosis and prognosis assessment of intensive care unit acquired weakness: A prospective study. Heart Lung. 2019 Nov-Dec;48(6):532-537. doi: 10.1016/j.hrtlng.2019.07.001. Epub 2019 Jul 15.
- Background: PubMed 27063347Jolley SE, Bunnell AE, Hough CL. ICU-Acquired Weakness. Chest. 2016 Nov;150(5):1129-1140. doi: 10.1016/j.chest.2016.03.045. Epub 2016 Apr 7.
- Background: PubMed 31277049Sidiras G, Patsaki I, Karatzanos E, Dakoutrou M, Kouvarakos A, Mitsiou G, Routsi C, Stranjalis G, Nanas S, Gerovasili V. Long term follow-up of quality of life and functional ability in patients with ICU acquired Weakness - A post hoc analysis. J Crit Care. 2019 Oct;53:223-230. doi: 10.1016/j.jcrc.2019.06.022. Epub 2019 Jun 21.
- Background: PubMed 28887062Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.
- Background: PubMed 32076765Vanhorebeek I, Latronico N, Van den Berghe G. ICU-acquired weakness. Intensive Care Med. 2020 Apr;46(4):637-653. doi: 10.1007/s00134-020-05944-4. Epub 2020 Feb 19.
- Background: PubMed 25450135Bohannon RW, Wang YC, Gershon RC. Two-minute walk test performance by adults 18 to 85 years: normative values, reliability, and responsiveness. Arch Phys Med Rehabil. 2015 Mar;96(3):472-7. doi: 10.1016/j.apmr.2014.10.006. Epub 2014 Oct 25.
- Background: PubMed 29730622Fuke R, Hifumi T, Kondo Y, Hatakeyama J, Takei T, Yamakawa K, Inoue S, Nishida O. Early rehabilitation to prevent postintensive care syndrome in patients with critical illness: a systematic review and meta-analysis. BMJ Open. 2018 May 5;8(5):e019998. doi: 10.1136/bmjopen-2017-019998.
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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.
Huan-Jui Yeh study chair
Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare
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 ICU Acquired Weakness and Weaning Failure, run by Taoyuan General Hospital 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 1 inclusion and 2 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 19 Jul 2021. 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?
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?
Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge (time frame: every day during the ICU stay until patients discharge from ICU assessed up to 14 days). The study lists 11 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 NCT04914065, which also lists 13 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 19 Jul 2021.