Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04553315
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2020-08-30
Brief Title:
the Effect of Chest Expansion Exercises on Pleural Effusion
Sponsor:
Sarah Asmaa
Organization:
Assiut University
Study Overview
Official Title:
The Effect of Chest Expansion Exercises on Reducing Pulmonary Infection and Complications in Patients With Pleural Effusion
Status:
COMPLETED
Status Verified Date:
2020-09
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:
PE
Brief Summary:
the study attempted to assess and evaluate the efficacy of implementing chest expansion exercises on patients with pleural effusion and how this programme contribute to reduce pulmonary infection and complications
To address the objective of the study the researcher utilized chest expansion exercises consisted of stacked breathing exercise segmental breathing chest mobility exercises deep breathing exercise with use of incentve spirometer and assess the patient before and after exercises by using three tools help to monitor hemodynamic parameters chest condition laboratory investigations which help to evaluate pulmonary infection score and complications
To address the objective of the study the researcher utilized chest expansion exercises consisted of stacked breathing exercise segmental breathing chest mobility exercises deep breathing exercise with use of incentve spirometer and assess the patient before and after exercises by using three tools help to monitor hemodynamic parameters chest condition laboratory investigations which help to evaluate pulmonary infection score and complications
Detailed Description:
Introduction Plural effusion is a syndrome occurs frequently in hospitalized patients leading to increased morbidity mortality and healthcare expenditure A plural effusion represents the disturbance of the normal mechanisms of formation and drainage of fluid from the plural space
Plural effusion is defined as a fluid collection between the plural leaves due to localsystemic disease of the pleura lung or extra-pulmonary organs Normally 01 to 02 mlkg of fluid is present in the plural leaves to facilitate plural movement When the balance between the production and re-absorption of this fluid deteriorates it becomes plural effusion
The accumulation of plural effusion has important effects on respiratory system function It changes the elastic equilibrium volumes of the lung and chest wall resulting in a restrictive ventilatory effect chest wall expansion and reduced efficiency of the inspiratory muscles The magnitude of these alterations depends on the plural fluid volume and the underlying disease of the respiratory system The decrease in lung volume is associated with hypoxemia mainly due to an increase in right to left shunt The drainage of pleural fluid results in an increase in lung volume that is considerably less than the amount of aspirated fluid while hypoxemia is not readily reversible upon fluid aspiration
Pleural effusions are traditionally classified as either transudates or exudates Diseases that affect the filtration of pleural fluid result in transudate formation and often occur bilaterally Inflammation or injury increases pleural capillary membrane permeability to proteins and various types of cells and lead to the formation of an exudative effusion
This study was designed as a randomised controlled trial to determine the effect of chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion
Methods Design Structured as a randomized-controlled prospective study the objective of this study was to determine the efficacy of the chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion
Setting Data was collected from chest ICU and critical ICU in Assiut university hospital
Sample The study population consisted of patients eighteen to sixty years old hospitalized and treated in Critical Chest intensive care units The inclusion criteria stipulated that the patient was between eighteen and sixty years old both genders were included diagnosed as plural effusion by the physician and with a symmetrical chest expansion and agreed to participate in the study A power calculation estimated that in order to detect an effect size of 029 difference in mean of pulmonary function between the two studied groups with a p-value 005 and 80 power confidence level 095 a sample size of 20 patients for each group was needed However 60 patients were attempted in this research work to avoid non-response rate 30 for each group This calculated using G Power 31 The study data was collected between June 2019 and June 2020
Instruments and measurements Three tools used in this study were developed by the researcher based on reviewing of the relevant literature
The first tool was Plural effusion assessment sheet used to monitor hemodynamic parameters included Mean arterial pressure MAP taken from bed side monitor heart rate HR temperature respiratory rate and CVP readings assessment of respiratory system consisted of Chest examination done every shift before and after exercise chest x-ray assessment Sputum and blood culture assessment Ventilator profile assessment assessment of plural procedures done assessment of clinical pulmonary infection score fluid balance assessment assessment of laboratory findings in addition to socio-demographic and medical data
The second tool is Chest expansion exercises sheet was developed by the researcher and used to assess exercises done to the patient and included Chest mobility exercise Stacked breathing exercise Segmental breathing exercise Deep breathing exercise and Incentive spirometer exercise
The third tool is Patients outcomes evaluation sheet which was developed by the researcher and used to assess the effect of chest expansion exercises on pulmonary infection score and complications
Intervention After getting ethical clearance patients were enrolled in the study patients were selected based on the inclusion and exclusion criteria Following an initial assessment the patients were assigned to one of the two groups by block randomization
Intervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique The patient in the intervention group was instructed to perform the exercises 3 times per day 7-8 times per session for one week Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of 30-35 mlkgday with restriction of intravenous fluids
Data collection The data were collected from the first day of admission after stabilization of the patients condition and extended to 7 days every day and every shift then the data were recorded in the developed toolsThe researcher assigned study sample 30 patients to two groups Control group Intervention group
For the control group The researcher assessed patients who were receiving the routine hospital care For Intervention group The researcher assessed patients then applying chest expansion exercises
Ethical considerations There was no risk for study subject during application of the study as the study followed common ethical principles in clinical research and has been carried out in accordance with The Code of Ethics of the World Medical Association Declaration of Helsinki and written consent was obtained from patients or guidance that participated in the study after explaining the nature and purpose of the study
Patient was assured that the data of this research was not be reused without second permission confidentiality and anonymity was assured and the patients had the right to refuse to participate or withdraw from the study without any rational at any time
Data analysis Data were computerized and analyzed by computer programmed SPSS ver16 Data were presented by using descriptive statistics in the form of frequencies and percentages or means standard deviations for qualitative data Quantitative data were compared using Independent samples t-test for comparisons among two groups Qualitative variables were compared using chi-square test to determine significance The critical value of the tests P was considered statistically significant when P less than 005
Plural effusion is defined as a fluid collection between the plural leaves due to localsystemic disease of the pleura lung or extra-pulmonary organs Normally 01 to 02 mlkg of fluid is present in the plural leaves to facilitate plural movement When the balance between the production and re-absorption of this fluid deteriorates it becomes plural effusion
The accumulation of plural effusion has important effects on respiratory system function It changes the elastic equilibrium volumes of the lung and chest wall resulting in a restrictive ventilatory effect chest wall expansion and reduced efficiency of the inspiratory muscles The magnitude of these alterations depends on the plural fluid volume and the underlying disease of the respiratory system The decrease in lung volume is associated with hypoxemia mainly due to an increase in right to left shunt The drainage of pleural fluid results in an increase in lung volume that is considerably less than the amount of aspirated fluid while hypoxemia is not readily reversible upon fluid aspiration
Pleural effusions are traditionally classified as either transudates or exudates Diseases that affect the filtration of pleural fluid result in transudate formation and often occur bilaterally Inflammation or injury increases pleural capillary membrane permeability to proteins and various types of cells and lead to the formation of an exudative effusion
This study was designed as a randomised controlled trial to determine the effect of chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion
Methods Design Structured as a randomized-controlled prospective study the objective of this study was to determine the efficacy of the chest expansion exercises on reducing pulmonary infection and complications on patients with plural effusion
Setting Data was collected from chest ICU and critical ICU in Assiut university hospital
Sample The study population consisted of patients eighteen to sixty years old hospitalized and treated in Critical Chest intensive care units The inclusion criteria stipulated that the patient was between eighteen and sixty years old both genders were included diagnosed as plural effusion by the physician and with a symmetrical chest expansion and agreed to participate in the study A power calculation estimated that in order to detect an effect size of 029 difference in mean of pulmonary function between the two studied groups with a p-value 005 and 80 power confidence level 095 a sample size of 20 patients for each group was needed However 60 patients were attempted in this research work to avoid non-response rate 30 for each group This calculated using G Power 31 The study data was collected between June 2019 and June 2020
Instruments and measurements Three tools used in this study were developed by the researcher based on reviewing of the relevant literature
The first tool was Plural effusion assessment sheet used to monitor hemodynamic parameters included Mean arterial pressure MAP taken from bed side monitor heart rate HR temperature respiratory rate and CVP readings assessment of respiratory system consisted of Chest examination done every shift before and after exercise chest x-ray assessment Sputum and blood culture assessment Ventilator profile assessment assessment of plural procedures done assessment of clinical pulmonary infection score fluid balance assessment assessment of laboratory findings in addition to socio-demographic and medical data
The second tool is Chest expansion exercises sheet was developed by the researcher and used to assess exercises done to the patient and included Chest mobility exercise Stacked breathing exercise Segmental breathing exercise Deep breathing exercise and Incentive spirometer exercise
The third tool is Patients outcomes evaluation sheet which was developed by the researcher and used to assess the effect of chest expansion exercises on pulmonary infection score and complications
Intervention After getting ethical clearance patients were enrolled in the study patients were selected based on the inclusion and exclusion criteria Following an initial assessment the patients were assigned to one of the two groups by block randomization
Intervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique The patient in the intervention group was instructed to perform the exercises 3 times per day 7-8 times per session for one week Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of 30-35 mlkgday with restriction of intravenous fluids
Data collection The data were collected from the first day of admission after stabilization of the patients condition and extended to 7 days every day and every shift then the data were recorded in the developed toolsThe researcher assigned study sample 30 patients to two groups Control group Intervention group
For the control group The researcher assessed patients who were receiving the routine hospital care For Intervention group The researcher assessed patients then applying chest expansion exercises
Ethical considerations There was no risk for study subject during application of the study as the study followed common ethical principles in clinical research and has been carried out in accordance with The Code of Ethics of the World Medical Association Declaration of Helsinki and written consent was obtained from patients or guidance that participated in the study after explaining the nature and purpose of the study
Patient was assured that the data of this research was not be reused without second permission confidentiality and anonymity was assured and the patients had the right to refuse to participate or withdraw from the study without any rational at any time
Data analysis Data were computerized and analyzed by computer programmed SPSS ver16 Data were presented by using descriptive statistics in the form of frequencies and percentages or means standard deviations for qualitative data Quantitative data were compared using Independent samples t-test for comparisons among two groups Qualitative variables were compared using chi-square test to determine significance The critical value of the tests P was considered statistically significant when P less than 005
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| sasmaa | REGISTRY | assiut university | None |