Effect of Glossopharyngeal Versus Diaphragmatic Breathing Exercise on Pulmonary Function After Decortication Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
This study will be conducted to compare between the effect of glossopharyngeal and diaphragmatic breathing exercises on pulmonary functions after decortication surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 24, 2024
CompletedStudy Start
First participant enrolled
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedApril 17, 2025
July 1, 2024
8 months
July 17, 2024
April 14, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
Tidal volume
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)
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)
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)
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)
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)
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)
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)
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
Study Arms (3)
Traditional chest techniques
ACTIVE COMPARATORthe patients will receive traditional chest techniques only
Traditional chest techniques +Glossopharyngeal breathing exercise
EXPERIMENTALthe patients will receive traditional chest techniques and glossopharyngeal breathing exercise
Traditional chest techniques +diaphragmatic breathing exercise
EXPERIMENTALthe patients will receive traditional chest techniques and diaphragmatic breathing exercise
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cancerous patient.
- Inability to comprehend and follow instructions as in dementia
- paralytic involvement of thorax muscle
- Abdominal diseases that affect diaphragmatic function
- Diaphragmatic paralysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Mai Gamal El-Din Mostafa
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nesreen El-Nahas, professor
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 24, 2024
Study Start
July 30, 2024
Primary Completion
March 15, 2025
Study Completion
March 31, 2025
Last Updated
April 17, 2025
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL