Correlation of the Hand Grip Force With Maximum Inspiratory and Maximum Expiratory Pressure, in Critical Ill Patients

March 6, 2018 updated by: Konstantinos Grigoriadis, Attikon Hospital
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

Study Overview

Detailed Description

Design of the study This is a random retrospective observational study concerned the period from 5/2017 to 1/2018. The study was conducted for patients of the 2nd General University Intensive Care Unit, of Attikon University General Hospital. The data studied as a sample are derived from file records of adult male and female ICU patients.

The inclusion - exclusion criteria

  • 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
  • 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 Measurements Τhe blindness of the study was ensured because both evaluators and patients don't know were participating in a study. The data from records on patient files related to the following: PEmax, PImax, HG, Age, Weight, Height, points in Glasgow Coma Scale, creatinine, use of inotrope drugs, partial pressure of oxygen (PaO2), platelets, bilirubin, oxygen supply (FiO2), cause of admission and day of hospitalization in the ICU. The last eight values are taken to calculate the SOFA to determine the severity of the condition of these patients. Finally, due to the use of historical data from the patient file, it was not considered necessary to obtain a paper consensus.

Statistical analysis Descriptive statistics are presented as means ± SD, medians and interquartile ranges, or percentages when appropriate. The Shapiro -Wilk test was used to determine whether the variables of interest followed a normal distribution. For the calculation of the correlation between parametric variables Pearson's correlation test was used, and for the calculation of the correlation between non parametric variables Spearman's rho was used. Rho coefficient correlation of <0.20 is considered to indicate very weak correlation, 0.21-0.40 indicates weak correlation, 0.41- 0.60 indicates moderate correlation and 0.61-0.80 indicates strong correlation. Finally a linear regression analysis was run to predict HGF from PEmax.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Attica
      • Athens, Attica, Greece, 12462
        • Attikon University Hospital
      • Athens, Attica, Greece, 18452
        • Grigoriadis Konstantinos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation PImax and Hand Grip Force
Time Frame: 9 Mοnths
Correlation PImax and Hand Grip Force
9 Mοnths
Correlation PEmax and Hand Grip Force
Time Frame: 9 Months
Correlation PEmax and Hand Grip Force
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Apostolos Armaganidis, Professor, Attikon University Hospital, ICU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (ACTUAL)

March 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • EBD2877/06-12-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intensive Care Unit Syndrome

Clinical Trials on Hand Grip Force

3
Subscribe