Pulmonary FunctionCPAPNCT04576221
Comparative Study Between CPAP Mask and Stacked Breathing o Pneumonia
A study testing stacked breathing exercise and NIV by CPAP mask in people with Pulmonary Function, run by Ahmed talaat ahmed aly at 1 site in Egypt.
Trial summary
the study aimed to compare the effect of using NIV with using CPAP mask and stacked breathing exercise and its efficacy on chest expansion and pulmonary functions in pneumonic patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Function
- What is being tested?
- stacked breathing exercise and NIV by CPAP mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 - 60 years.
- patients of both genders.
- patients diagnosed with pneumonia.
Who cannot join
- Orthopedic conditions.
- Malignant conditions.
- Cognitive impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between NIV With Using CPAP Mask Versus Stacked Breathing on Chest Expansion and Pulmonary Function in Patient With Pneumonia
the study aimed to compare the effect of using NIV with using CPAP mask and stacked breathing exercise and its efficacy on chest expansion and pulmonary functions in pneumonic patients.
Read the detailed description
Introduction Pneumonia represents a frequent complication in patients in ICU with rates up to 56% . Although oxygen therapy is the cornerstone for pneumonia treatment, its efficacy might be minimized because of shunt effects due to the presence of pulmonary exudate and atelectasis. To improve oxygenation, alveolar recruitment obtained through the application of either invasive or non-invasive mechanical ventilation (NIV) might be necessary, especially in severe pneumonia .
The role of NIV as a tool to treat pneumonia has dramatically increased over the past decades and its efficacy has been well studied in clinical practice, especially in treating acute cardiogenic pulmonary edema and exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Concerning NIV treatment in patients with pneumonia, its use has been proved to be effective only in patients with COPD and in immunocompromised patients with lung infiltrates . The lack of strong evidence in literature led international experts to suggest only cautious trials of NIV in well-selected patients with pneumonia and in trained settings with a clear caveat to avoid a delay in endotracheal intubation . One method of NIV is Continuous Positive Airway Pressure (CPAP) which is used to administer fresh gas pressure to the spontaneously breathing patient. By opening more alveolar spaces, CPAP increases the number of functional airways, thereby reducing total resistance. The success of CPAP therapy is highly influenced by patient compliance and the level of comfort provided by the CPAP mask and headgear. If the patient is able to tolerate CPAP and use it correctly, its effective rate is nearly 100% . The majority of patients fail the treatment not because of its low efficacy for maintaining upper airway patency but because of intolerance .
There are different types of physiotherapy exercises which can benefit patient with pneumonia and help lung recruitment as CPAP ventilation but it is more tolerance to patient than use of CPAP mask . one of these exercises is breathing stacking which is a breathing exercise to help improve and maintain the size of breath that the patient is able to take and can be used regularly to help the patient clear mucus from his chest (secretion clearance).
It can also be used to help improve the strength of the cough and voice . It is mainly used for people with weak breathing muscles which makes breathing and coughing difficult. Patients with neuromuscular diseases often have weakness of their breathing (respiratory) muscles which affects how well the respiratory system works. It is also used for people with bone or structural problems which cause a small / altered chest shape making coughing difficult .
The aim of this study is to compare the effect of NIV with using CPAP mask versus stacked breathing on chest expansion and pulmonary function in patients with pneumonia .
Research hypothesis:- the investigators hypothesized that stacked breathing exercise is more effective on chest expansion and pulmonary function and more tolerant to patients with pneumonia than NIV with using CPAP mask.
Patients and methods Research design:- Quasi experimental research design will be utilized to fulfill the aim of this study.
Study variables:-
- The independent variables are NIV with using CPAP mask and stacked breathing exercise . -The dependent variables are the patients ' outcomes which include:-
- Chest expansion.
- Pulmonary functions.
- Duration of ICU stay.
- Complications as respiratory complications and general complications.
- Mortality rate. Research settings: The study will be conducted in 4 settings include:- Chest intensive care unit at Assiut university hospital. General intensive care unit at Assiut university hospital. Obstetric intensive care at women health hospital. Trauma intensive care unit at Assiut university hospital. Sample:- A convenience sample of 60 male and female adult patients will be taken, the patients will be classified into two equal groups , 30 patients for each group. CPAP mask group will receive NIV with using CPAP mask and stacked breathing group who will receive stacked breathing exercise. Tools of the study:- The following tools will be used to collect data for study:- Tool [1]:- patient assessment sheet which will be developed by the researcher and uses to monitor hemodynamic parameters, assessment of respiratory system, assessment of laboratory findings , fluid balance in addition to socio-demographic and medical data . It includes 5 parts:- Part (1): Socio-demographic and medical data as patient code , age , sex , past history , present illness, cause of admission , date of admission, date of discharge and length of ICU stay. This part also includes assessments of hemodynamic parameters system include (Mean arterial pressure (MAP), heart rate (HR), temperature and CVP readings) and laboratory findings every day. Part (3): Assessment of respiratory system which includes :-
- Chest condition as respiratory rate ,cough (dry or productive, strong or weak ), sputum characteristics: (amount , viscosity and color), dyspnea , orthopnea , pain with breathing and also assessment of sputum and blood culture.
- Auscultation of the chest for breathing sounds and determine if there are abnormal breathing e.g [wheezing, bronchospasm, crepitation .....] every shift.
- chest x-ray and ventilator profile.
- Assessment of chest expansion.
- Assessment of pulmonary functions Part (4): Fluid balance chart which include fluid intake and output. Part (5):Medication chart. Tool [2]: pneumonia treatment sheet which will be developed by researcher and uses to assess procedures done to the patient and includes 5 parts:- Part (1) : NIV with using CPAP mask. Part (2) : Stacked breathing exercise Tool [3]: Outcome evaluation sheet which will be developed by the researcher and uses to assess the effect of NIV with using CPAP mask and Stacked breathing on :-
- Chest expansion .
- Pulmonary functions.
- Days of staying in ICU.
- Complications such as pulmonary complications as pulmonary edema, bronchitis , pulmonary embolism , respiratory failure ...others and general complications as acute renal failure , liver failure , multiple organ failure or …..others.
- Mortality rate.
- Conditions
- Pulmonary Function
- Being tested
- stacked breathing exercise, NIV by CPAP mask
- Keywords
- stacked breathing, CPAP mask, pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stacked breathing exerciseDevice
- Breath stacking was done using a "bag" which is a simple device used to give artificial breaths..
- It is best done in a sitting position but can be done reclining or lying flat whichever position is used, try to avoid slouching. If sitting: rest against the back of a chair and keep the shoulders, arms and hands relaxed.
- If using the mouthpiece, place the lips tightly around the mouthpiece to create a tight seal.
NIV by CPAP maskDevice
provides pressurized air through a mask to help push air into your lungs and help you breathe
| Study group | Role | What they receive |
|---|---|---|
| stacked breathing group | Experimental | experimental group received staked breathing exercise for 7 days , 3 sessions per day, 7-8 times per session Receives: Device: stacked breathing exercise |
| CPAP group | Experimental | experimental group received NIV with CPAP mask Receives: Device: NIV by CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
change chest expansion to the normal range
change chest expansion as chest expansion measures will be in the normal range and it is measured by measuring tape in CM before and after the procedure
Measured: for 7 days
change pulmonary functions to the normal values
pulmonary functions will be assessed by bed side pulmonary function test as Schneider's match blowing test .
Measured: for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Jan 2020
- Primary completion30 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- use of two manner of breathing for patients with pneumonia.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed talaat ahmed aly
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Ahmed talaat ahmed aly, Assiut University
- Investigators
- Amal A Mohamed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576221
- Sponsor's protocol ID
- stacked breathing
- Acronym
- CPAP
- Status last verified
- Oct 2020
- First submitted
- 31 Aug 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between NIV With Using CPAP Mask Versus Stacked Breathing on Chest Expansion and Pulmonary Function in Patient With Pneumonia
- ClinicalTrials.gov ID
- NCT04576221
- Acronym / sponsor ID
- CPAP / stacked breathing
- Conditions
- Pulmonary Function
- Keywords
- stacked breathing, CPAP mask, pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ahmed talaat ahmed alyUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study aimed to compare the effect of using NIV with using CPAP mask and stacked breathing exercise and its efficacy on chest expansion and pulmonary functions in pneumonic patients.
Detailed description
Introduction Pneumonia represents a frequent complication in patients in ICU with rates up to 56% . Although oxygen therapy is the cornerstone for pneumonia treatment, its efficacy might be minimized because of shunt effects due to the presence of pulmonary exudate and atelectasis. To improve oxygenation, alveolar recruitment obtained through the application of either invasive or non-invasive mechanical ventilation (NIV) might be necessary, especially in severe pneumonia .
The role of NIV as a tool to treat pneumonia has dramatically increased over the past decades and its efficacy has been well studied in clinical practice, especially in treating acute cardiogenic pulmonary edema and exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Concerning NIV treatment in patients with pneumonia, its use has been proved to be effective only in patients with COPD and in immunocompromised patients with lung infiltrates . The lack of strong evidence in literature led international experts to suggest only cautious trials of NIV in well-selected patients with pneumonia and in trained settings with a clear caveat to avoid a delay in endotracheal intubation . One method of NIV is Continuous Positive Airway Pressure (CPAP) which is used to administer fresh gas pressure to the spontaneously breathing patient. By opening more alveolar spaces, CPAP increases the number of functional airways, thereby reducing total resistance. The success of CPAP therapy is highly influenced by patient compliance and the level of comfort provided by the CPAP mask and headgear. If the patient is able to tolerate CPAP and use it correctly, its effective rate is nearly 100% . The majority of patients fail the treatment not because of its low efficacy for maintaining upper airway patency but because of intolerance .
There are different types of physiotherapy exercises which can benefit patient with pneumonia and help lung recruitment as CPAP ventilation but it is more tolerance to patient than use of CPAP mask . one of these exercises is breathing stacking which is a breathing exercise to help improve and maintain the size of breath that the patient is able to take and can be used regularly to help the patient clear mucus from his chest (secretion clearance).
It can also be used to help improve the strength of the cough and voice . It is mainly used for people with weak breathing muscles which makes breathing and coughing difficult. Patients with neuromuscular diseases often have weakness of their breathing (respiratory) muscles which affects how well the respiratory system works. It is also used for people with bone or structural problems which cause a small / altered chest shape making coughing difficult .
The aim of this study is to compare the effect of NIV with using CPAP mask versus stacked breathing on chest expansion and pulmonary function in patients with pneumonia .
Research hypothesis:- the investigators hypothesized that stacked breathing exercise is more effective on chest expansion and pulmonary function and more tolerant to patients with pneumonia than NIV with using CPAP mask.
Patients and methods Research design:- Quasi experimental research design will be utilized to fulfill the aim of this study.
Study variables:-
- The independent variables are NIV with using CPAP mask and stacked breathing exercise . -The dependent variables are the patients ' outcomes which include:-
- Chest expansion.
- Pulmonary functions.
- Duration of ICU stay.
- Complications as respiratory complications and general complications.
- Mortality rate. Research settings: The study will be conducted in 4 settings include:- Chest intensive care unit at Assiut university hospital. General intensive care unit at Assiut university hospital. Obstetric intensive care at women health hospital. Trauma intensive care unit at Assiut university hospital. Sample:- A convenience sample of 60 male and female adult patients will be taken, the patients will be classified into two equal groups , 30 patients for each group. CPAP mask group will receive NIV with using CPAP mask and stacked breathing group who will receive stacked breathing exercise. Tools of the study:- The following tools will be used to collect data for study:- Tool [1]:- patient assessment sheet which will be developed by the researcher and uses to monitor hemodynamic parameters, assessment of respiratory system, assessment of laboratory findings , fluid balance in addition to socio-demographic and medical data . It includes 5 parts:- Part (1): Socio-demographic and medical data as patient code , age , sex , past history , present illness, cause of admission , date of admission, date of discharge and length of ICU stay. This part also includes assessments of hemodynamic parameters system include (Mean arterial pressure (MAP), heart rate (HR), temperature and CVP readings) and laboratory findings every day. Part (3): Assessment of respiratory system which includes :-
- Chest condition as respiratory rate ,cough (dry or productive, strong or weak ), sputum characteristics: (amount , viscosity and color), dyspnea , orthopnea , pain with breathing and also assessment of sputum and blood culture.
- Auscultation of the chest for breathing sounds and determine if there are abnormal breathing e.g [wheezing, bronchospasm, crepitation .....] every shift.
- chest x-ray and ventilator profile.
- Assessment of chest expansion.
- Assessment of pulmonary functions Part (4): Fluid balance chart which include fluid intake and output. Part (5):Medication chart. Tool [2]: pneumonia treatment sheet which will be developed by researcher and uses to assess procedures done to the patient and includes 5 parts:- Part (1) : NIV with using CPAP mask. Part (2) : Stacked breathing exercise Tool [3]: Outcome evaluation sheet which will be developed by the researcher and uses to assess the effect of NIV with using CPAP mask and Stacked breathing on :-
- Chest expansion .
- Pulmonary functions.
- Days of staying in ICU.
- Complications such as pulmonary complications as pulmonary edema, bronchitis , pulmonary embolism , respiratory failure ...others and general complications as acute renal failure , liver failure , multiple organ failure or …..others.
- Mortality rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- use of two manner of breathing for patients with pneumonia.
| Arm | Type | Receives |
|---|---|---|
| stacked breathing group | Experimental | Device: stacked breathing exerciseexperimental group received staked breathing exercise for 7 days , 3 sessions per day, 7-8 times per session |
| CPAP group | Experimental | Device: NIV by CPAP maskexperimental group received NIV with CPAP mask |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age of 18 - 60 years.
- patients of both genders.
- patients diagnosed with pneumonia.
Key exclusion criteria (3 listed)
- Orthopedic conditions.
- Malignant conditions.
- Cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stacked breathing exercise• Breath stacking was done using a "bag" which is a simple device used to give artificial breaths.. * It is best done in a sitting position but can be done reclining or lying flat whichever position is used, try to avoid slouching. If sitting: rest against the back of a chair and keep the shoulders, arms and hands relaxed. * If using the mouthpiece, place the lips tightly around the mouthpiece to create a tight seal. | Device | stacked breathing group |
| NIV by CPAP maskprovides pressurized air through a mask to help push air into your lungs and help you breathe | Device | CPAP group |
Primary outcome
change chest expansion to the normal range
Time frame: for 7 days
change chest expansion as chest expansion measures will be in the normal range and it is measured by measuring tape in CM before and after the procedure
change pulmonary functions to the normal values
Time frame: for 7 days
pulmonary functions will be assessed by bed side pulmonary function test as Schneider's match blowing test .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal A Mohamed, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stacked breathing exercise and NIV by CPAP mask in people with Pulmonary Function, run by Ahmed talaat ahmed aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change chest expansion to the normal range (time frame: for 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020; AzTrials last refreshed its copy on 4 Nov 2026.