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Comparative Study Between CPAP Mask and Stacked Breathing o Pneumonia (CPAP)

Primary Purpose

Pulmonary Function

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stacked breathing exercise
NIV by CPAP mask
Sponsored by
Ahmed talaat ahmed aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Function focused on measuring stacked breathing, CPAP mask, pneumonia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Orthopedic conditions.
  • Malignant conditions.
  • Cognitive impairments.

Sites / Locations

  • Assiut University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

stacked breathing group

CPAP group

Arm Description

experimental group received staked breathing exercise for 7 days , 3 sessions per day, 7-8 times per session

experimental group received NIV with CPAP mask

Outcomes

Primary Outcome Measures

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
change pulmonary functions to the normal values
pulmonary functions will be assessed by bed side pulmonary function test as Schneider's match blowing test .

Secondary Outcome Measures

Full Information

First Posted
August 31, 2020
Last Updated
October 1, 2020
Sponsor
Ahmed talaat ahmed aly
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04576221
Brief Title
Comparative Study Between CPAP Mask and Stacked Breathing o Pneumonia
Acronym
CPAP
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed talaat ahmed aly
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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:- 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Function
Keywords
stacked breathing, CPAP mask, pneumonia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
use of two manner of breathing for patients with pneumonia.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stacked breathing group
Arm Type
Experimental
Arm Description
experimental group received staked breathing exercise for 7 days , 3 sessions per day, 7-8 times per session
Arm Title
CPAP group
Arm Type
Experimental
Arm Description
experimental group received NIV with CPAP mask
Intervention Type
Device
Intervention Name(s)
stacked breathing exercise
Intervention Description
• 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.
Intervention Type
Device
Intervention Name(s)
NIV by CPAP mask
Intervention Description
provides pressurized air through a mask to help push air into your lungs and help you breathe
Primary Outcome Measure Information:
Title
change chest expansion to the normal range
Description
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
Time Frame
for 7 days
Title
change pulmonary functions to the normal values
Description
pulmonary functions will be assessed by bed side pulmonary function test as Schneider's match blowing test .
Time Frame
for 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal A Mohamed, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospitals
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD

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Comparative Study Between CPAP Mask and Stacked Breathing o Pneumonia

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