- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06518759
Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery
Study Overview
Status
Conditions
Detailed Description
Lung decortication is a well-known procedure for the treatment of empyema. Persistent lung collapse and non-expansion of the lung parenchyma are frequently noticed in the postoperative period after decortications, chest physiotherapy plays a crucial role in the re-expansion of underlying parenchyma.
There is an increased flow of patients after decortication surgery to hospitals who suffer from decreased lung volumes so the hospitalization period for them increases which puts an economical burden on health insurance services with a decreased level of quality of life that is the most concern to improve patient status and relieve this burden. So this study aims to improve patient's lung volumes and arterial blood gas parameters which improves patient status through two various forms of breathing exercises.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Mai Gamal El-Din Mostafa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participant's body mass index (BMI) will be ranged from 25- 29.9 kg/m2
- The patient will receive treatment after 24 hours after decortication
- The study will be in the intensive care unit (ICU).
- The patients have unilateral lung decortication
- Their vital capacity is 70% or less.
Exclusion Criteria:
- Cancerous patient.
- Inability to comprehend and follow instructions as in dementia
- paralytic involvement of thorax muscle
- Abdominal diseases that affect diaphragmatic function
- Diaphragmatic paralysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional chest techniques
the patients will receive traditional chest techniques only
|
patients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks
|
|
Experimental: Traditional chest techniques +Glossopharyngeal breathing exercise
the patients will receive traditional chest techniques and glossopharyngeal breathing exercise
|
patients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks
patients will receive Glossopharyngeal breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.
|
|
Experimental: Traditional chest techniques +diaphragmatic breathing exercise
the patients will receive traditional chest techniques and diaphragmatic breathing exercise
|
patients will receive traditional chest techniques in the form of percussion and vibration, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks
patients will receive diaphragmatic breathing exercise, 2 times per day, 3 sets 5 repetitions per each set for 20 minutes, 3 times per week for 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tidal volume
Time Frame: within 2 weeks
|
The spirometer device (Meditech, made in China) will be used to measure tidal volume for all participants in all groups before and after the treatment program.
It is the amount of air that moves in or out of the lungs with each respiratory cycle.
It measures about 400 ml in a healthy female.
|
within 2 weeks
|
|
Inspiratory reserve volume (IRV)
Time Frame: within 2 weeks
|
The spirometer device (Meditech, made in China) will be used to measure inspiratory reserve volume (IRV) for all participants in all groups before and after the treatment program. - IRV: It is the amount of air that can be forcibly inhaled after normal tidal volume. The normal adult value is 1900-3300 ml. |
within 2 weeks
|
|
Expiratory reserve volume (ERV)
Time Frame: within 2 weeks
|
The spirometer device (Meditech, made in China) will be used to measure expiratory reserve volume (ERV) for all participants in all groups before and after the treatment program. ERV: It is the amount of extra air above normal breath-exhaled during forceful breath out, its average is about 800ml in females. |
within 2 weeks
|
|
Measurement of the potential of hydrogen (PH)
Time Frame: within 2 weeks
|
Blood gas analyzer will be used to measure the potential of hydrogen (PH) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of pH is7.35-7.45 |
within 2 weeks
|
|
Measurement of the partial arterial pressure of carbon dioxide(PaCO2)
Time Frame: within 2 weeks
|
Blood gas analyzer will be used to measure the partial arterial pressure of carbon dioxide(PaCO2) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. the normative value of PaCO2 is 4.7-6 KPa. |
within 2 weeks
|
|
Measurement of the partial arterial pressure of oxygen (PaO2)
Time Frame: within 2 weeks
|
Blood gas analyzer will be used to measure the partial arterial pressure of oxygen (PaO2)for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. the normative value of Pao2 is 1.7-13.3 KPa. |
within 2 weeks
|
|
Measurement of the Bicarbonate (HCO3)
Time Frame: within 2 weeks
|
Blood gas analyzer will be used to measure the Bicarbonate (HCO3) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of HCO3 is 22-26 mmol/L. |
within 2 weeks
|
|
Measurement of oxygen saturation (SO2)
Time Frame: within 2 weeks
|
Blood gas analyzer will be used to measure oxygen saturation (SO2) for all participants in all groups before and after the treatment program. The blood sample was taken from the radial or brachial or femoral artery or from arterial catheter and put in the device. The normative value of SO2 is 95-100%.. |
within 2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nesreen El-Nahas, professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003896
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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