Predictors of Prognosis in Patients With Critical Illness.

NCT04914065 | Completed

• 1 other identifier: TYGH108031
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• Part 2: Respiratory muscle strength

  Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)

  the day that patient received weaning profile tests during ICU

• 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

• Part 2: Physical function at ICU discharge

  2 mins walk test

  conducted at the day of ICU discharge

• Part 2: Change of Delirium

  CAM-ICU

  conducted every day in the ICU

• Part 2: Respiratory function

  FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)

  conducted at the day of ICU discharge

• Part 2: Quality of life- SF-36(Taiwan version)

  SF-36(Taiwan version)

  conducted by phone call at discharge for 6 months from ICU

Interventions

Regular care in the surgery intensive care unit OTHER

Part 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taoyuan General Hospital: lead
• National Yang Ming Chiao Tung University: collaborator
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan

Taoyuan District, 330, Taiwan

Location

Related Publications (13)

• 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.

  PMID: 32164739 BACKGROUND

• 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. 2021 Nov;36(11):1313-1322. doi: 10.1177/0885066620949178. Epub 2020 Aug 17.

  PMID: 32799703 BACKGROUND

• 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.

  PMID: 25759461 BACKGROUND

• 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.

  PMID: 28746528 BACKGROUND

• 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.

  PMID: 32387152 BACKGROUND

• Braganca 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.

  PMID: 31320179 BACKGROUND

• 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.

  PMID: 27063347 BACKGROUND

• 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.

  PMID: 31277049 BACKGROUND

• 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.

  PMID: 28887062 BACKGROUND

• 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.

  PMID: 32076765 BACKGROUND

• 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.

  PMID: 25450135 BACKGROUND

• 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.

  PMID: 29730622 BACKGROUND

• 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.

  PMID: 27274515 BACKGROUND

Study Officials

• Huan-Jui Yeh

  Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 4, 2021
• Study Start: January 1, 2020
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: July 19, 2021

Record last verified: 2021-07

Locations

TW (1)