Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03457376
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2018-03-01
Brief Title:
Correlation of the Hand Grip Force With Maximum Inspiratory and Maximum Expiratory Pressure in Critical Ill Patients
Sponsor:
Attikon Hospital
Organization:
Attikon Hospital
Study Overview
Official Title:
Correlation of the Hand Grip Force With Maximum Inspiratory and Maximum Expiratory Pressure in Critical Ill Patients
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Design of the study This is a random retrospective observational study concerned the period from 52017 to 12018 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 dont 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 Pearsons correlation test was used and for the calculation of the correlation between non parametric variables Spearmans rho was used Rho coefficient correlation of 020 is considered to indicate very weak correlation 021-040 indicates weak correlation 041- 060 indicates moderate correlation and 061-080 indicates strong correlation Finally a linear regression analysis was run to predict HGF from PEmax
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 dont 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 Pearsons correlation test was used and for the calculation of the correlation between non parametric variables Spearmans rho was used Rho coefficient correlation of 020 is considered to indicate very weak correlation 021-040 indicates weak correlation 041- 060 indicates moderate correlation and 061-080 indicates strong correlation Finally a linear regression analysis was run to predict HGF from PEmax
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None