Predictors of Prognosis in Patients With Critical Illness.

Quality of Life Clinical Trial

Official title:

Predictors of Prognosis in Patients With Critical Illness.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914065
• Other study ID #: TYGH108031
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: July 2021
• Source: Taoyuan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU

Exclusion Criteria:

• Hemodynamic instability patients, e.g., patients with ECMO
• Patients refuse to participate this study

Related Conditions & MeSH terms

• Critical Illness
• ICU Acquired Weakness
• Quality of Life
• Weaning Failure

Intervention

Other:
• Regular care in the surgery intensive care unit
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)

Locations

Country	Name	City	State
Taiwan	Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan	Taoyuan

Sponsors (3)

Lead Sponsor	Collaborator
Taoyuan General Hospital	Ministry of Science and Technology, R.O.C., National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (13)

Bohannon 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. — View Citation

Bragança RD, Ravetti CG, Barreto L, Ataíde 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. — View Citation

Cottereau 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. — View Citation

Fuke 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. — View Citation

Jolley 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. Review. — View Citation

Kutchak 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. English, Portuguese. — View Citation

Meyer-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. 2020 Aug 17:885066620949178. doi: 10.1177/0885066620949178. [Epub ahead of print] — View Citation

Saiphoklang 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. — View Citation

Sidiras 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. — View Citation

Supinski 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. Review. — View Citation

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. — View Citation

Vanhorebeek 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. Review. — View Citation

Zein H, Baratloo A, Negida A, Safari S. Ventilator Weaning and Spontaneous Breathing Trials; an Educational Review. Emerg (Tehran). 2016 Spring;4(2):65-71. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	every day during the ICU stay until patients discharge from ICU assessed up to 14 days
Primary	Part 1: Change of diaphragm thickness from ICU admission to ICU discharge	Muscle thickness of diaphragm and quadriceps detected by ultrasound(GE vivid S5)	every day during the ICU stay until patients discharge from ICU assessed up to 14 days
Primary	Part 2: Change of Handgrip strength (HGS)	Change of Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Primary	Part 2: Change of General muscle strength	Change of General muscle strength- MRC scale	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Primary	Part 2: Change of Muscle mass	Muscle thickness of diaphragm and quadriceps detected by ultrasound (GE vivid S5)	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Primary	Part 2: Respiratory muscle strength	Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)	the day that patient received weaning profile tests during ICU
Primary	Part 2: Change of Physical function	Change of FSS-ICU	Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
Primary	Part 2: Physical function at ICU discharge	2 mins walk test	conducted at the day of ICU discharge
Primary	Part 2: Change of Delirium	CAM-ICU	conducted every day in the ICU
Primary	Part 2: Respiratory function	FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)	conducted at the day of ICU discharge
Primary	Part 2: Quality of life- SF-36(Taiwan version)	SF-36(Taiwan version)	conducted by phone call at discharge for 6 months from ICU