NCT03457376

Brief Summary

This study aimed to examine the relationship between Hand Grip Force (HGF), Maximum Inspiratory Pressure (PImax) and Maximum Expiratory Pressure (PEmax) in ICU tracheostomized patients. METHODS: All patients underwent assessment of PImax and PEmax by a membrane-type manometer, and for the measure of HGF an hydraulic hand dynamometer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

March 1, 2018

Last Update Submit

March 6, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Correlation PImax and Hand Grip Force

    Correlation PImax and Hand Grip Force

    9 Mοnths

  • Correlation PEmax and Hand Grip Force

    Correlation PEmax and Hand Grip Force

    9 Months

Interventions

Hand Grip ForceDIAGNOSTIC_TEST

Hand Grip Force

Maximal Inspiratory Pressure

Maximal Expiratory Pressure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ICU patients Tracheostomized Age, mean ± SD; median (IQR) y 67.2 ± 13.6; 74 (59.6-74.7) Male subjects 12 Weight, mean ± SD; median (IQR) kg 80 ± 15.2; 75 (71.5-88.4) Height, mean ± SD; median (IQR) cm 169 ± 9; 170 (164-174) PImax, mean ± SD; median (IQR) cm H2O 36.4 ± 12.1; 35 (29.6-43.1) PEmax, mean ± SD; median (IQR) cm H2O 40 ± 11.5; 40 (33.9-46.8) HGF, mean ± SD; median (IQR) kg 10.8 ± 7.9; 10 (6.3-15.2) BMI, mean ± SD; median (IQR) kg/m2 27.8 ± 5.4; 27.8 (24.7-30.8) ICU day of Hospitalization 20.6 ± 8.4; 20 (15.9-25.3) SOFA score 3.5 ± 1.5; 3 (2.6-4.3)

You may qualify if:

  • Adult ICU patients
  • Stable haemodynamic
  • Who were able to perform commands from breathing exercises in their hospitals in the ICU (Glasgow Comma Scale 15) good communication and level of consciousness in order to be able to execute orders
  • Have integers limbs
  • Were tracheostomy (measurements in this case result from a special adapter in the tracheostomy that ensures minimization of losses)
  • Their stay in the ICU should have been more than 11 days (the incidence of ICU muscle weakness occurs after 7 days of hospitalization19).
  • In order to ensure the randomness of the sample, records of patients who were only hospitalized on an even bed number.
  • All requirements for patient recruitment were solely for the day of the study

You may not qualify if:

  • They should not suffer from any neurological syndrome (central or peripheral type) other than the ICU acquired weakness, or even craniocerebral injury that could have an effect on the peripheral muscle strength.
  • Without drugs that could affect perception or muscle tone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Attikon University Hospital

Athens, Attica, 12462, Greece

Location

Grigoriadis Konstantinos

Athens, Attica, 18452, Greece

Location

Related Publications (7)

  • De Jonghe B, Bastuji-Garin S, Durand MC, Malissin I, Rodrigues P, Cerf C, Outin H, Sharshar T; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Respiratory weakness is associated with limb weakness and delayed weaning in critical illness. Crit Care Med. 2007 Sep;35(9):2007-15. doi: 10.1097/01.ccm.0000281450.01881.d8.

    PMID: 17855814BACKGROUND
  • Bahat G, Tufan A, Ozkaya H, Tufan F, Akpinar TS, Akin S, Bahat Z, Kaya Z, Kiyan E, Erten N, Karan MA. Relation between hand grip strength, respiratory muscle strength and spirometric measures in male nursing home residents. Aging Male. 2014 Sep;17(3):136-40. doi: 10.3109/13685538.2014.936001. Epub 2014 Jul 4.

    PMID: 24993454BACKGROUND
  • Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. doi: 10.1159/000050458.

  • Steier J, Kaul S, Seymour J, Jolley C, Rafferty G, Man W, Luo YM, Roughton M, Polkey MI, Moxham J. The value of multiple tests of respiratory muscle strength. Thorax. 2007 Nov;62(11):975-80. doi: 10.1136/thx.2006.072884. Epub 2007 Jun 8.

  • Shin HI, Kim DK, Seo KM, Kang SH, Lee SY, Son S. Relation Between Respiratory Muscle Strength and Skeletal Muscle Mass and Hand Grip Strength in the Healthy Elderly. Ann Rehabil Med. 2017 Aug;41(4):686-692. doi: 10.5535/arm.2017.41.4.686. Epub 2017 Aug 31.

  • Efstathiou ID, Mavrou IP, Grigoriadis KE. Correlation Between Maximum Inspiratory Pressure and Hand-Grip Force in Healthy Young and Middle-Age Individuals. Respir Care. 2016 Jul;61(7):925-9. doi: 10.4187/respcare.04319. Epub 2016 Apr 19.

  • Grigoriadis K, Efstathiou I, Dimitriadis Z, Konstantopoulou G, Grigoriadou A, Vasileiadis G, Micha M, Tsagaris I, Armaganidis A. Handgrip Force and Maximum Inspiratory and Expiratory Pressures in Critically Ill Patients With a Tracheostomy. Am J Crit Care. 2021 Mar 1;30(2):e48-e53. doi: 10.4037/ajcc2021248.

MeSH Terms

Interventions

Maximal Respiratory Pressures

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Apostolos Armaganidis, Professor

    Attikon University Hospital, ICU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc, PhD

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 7, 2018

Study Start

May 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations