ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03457376
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Konstantinos Grigoriadis, Attikon Hospital

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

Condition or disease Intervention/treatment
Intensive Care Unit Syndrome Diagnostic Test: Hand Grip Force Diagnostic Test: Maximal Inspiratory Pressure Diagnostic Test: Maximal Expiratory Pressure

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
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Correlation of the Hand Grip Force With Maximum Inspiratory and Maximum Expiratory Pressure, in Critical Ill Patients
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu


Intervention Details:
  • Diagnostic Test: Hand Grip Force
    Hand Grip Force
  • Diagnostic Test: Maximal Inspiratory Pressure
    Maximal Inspiratory Pressure
  • Diagnostic Test: Maximal Expiratory Pressure
    Maximal Expiratory Pressure


Primary Outcome Measures :
  1. Correlation PImax and Hand Grip Force [ Time Frame: 9 Mοnths ]
    Correlation PImax and Hand Grip Force

  2. Correlation PEmax and Hand Grip Force [ Time Frame: 9 Months ]
    Correlation PEmax and Hand Grip Force



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457376


Locations
Greece
Attikon University Hospital
Athens, Attica, Greece, 12462
Grigoriadis Konstantinos
Athens, Attica, Greece, 18452
Sponsors and Collaborators
Attikon Hospital
Investigators
Study Director: Apostolos Armaganidis, Professor Attikon University Hospital, ICU

Publications of Results:
Other Publications:
Responsible Party: Konstantinos Grigoriadis, PT, MSc, PhD, Attikon Hospital
ClinicalTrials.gov Identifier: NCT03457376     History of Changes
Other Study ID Numbers: EBD2877/06-12-2017
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No