Clinical trial NCT04576221: Comparative Study Between CPAP Mask and Stacked Breathing o Pneumonia
Official title: Comparative Study Between NIV With Using CPAP Mask Versus Stacked Breathing on Chest Expansion and Pulmonary Function in Patient With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Function
Keywords: stacked breathing
CPAP mask
pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2020-10-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: use of two manner of breathing for patients with pneumonia.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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:-

  1. Chest expansion.
  2. Pulmonary functions.
  3. Duration of ICU stay.
  4. Complications as respiratory complications and general complications.
  5. 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.

Eligibility criteria: Inclusion Criteria:

* Age of 18 - 60 years.
* patients of both genders.
* patients diagnosed with pneumonia.

Exclusion Criteria:

* Orthopedic conditions.
* Malignant conditions.
* Cognitive impairments.

Primary outcomes:
measure: change chest expansion to the normal range
timeFrame: for 7 days
measure: change pulmonary functions to the normal values
timeFrame: for 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
Study officials:
affiliation: Assiut University
name: Amal A Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References: