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Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

Primary Purpose

Pneumonia Hospital Acquired

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The Incentive Spirometer
The breather respiratory muscle training device
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia Hospital Acquired focused on measuring Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Sixty patients of both sexes from intensive care unit, Cairo University Hospitals. Their age ranged from 30 to 40 years old. Their BMI were from 25 - 29.9 Kg/m2. Their oxygen saturation 90 - 95% (mild hypoxemia) conscious level. Exclusion Criteria: 1. Patient with a history of any malignant tumors. 2. Patients with hearing impairment or mental disorder. 3. Patients with auto-immune diseases. 4. Patients with a history of any surgical transplantation. 5. Patients with hemo-dynamically unstable patients. 6. Patients with rib fracture. 7. Patients with history of neuromuscular disease. 8. Patients with spinal injuries. 9. Patients with BMI > 30 Kg/m2. 10. Patients receiving mechanical ventilation. -

Sites / Locations

  • Faculty of Physical Therapy - Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The Incentive Spirometer group

The Breather Respiratory Muscle Trainer group

Arm Description

The respiratory muscle training program has the following parameters: Duration: 20 minutes per session, Intensity: Clinical adjustment of training intensity based on actual participants' status across session time, holding time, and repetitions. Frequency: 30 per set, with each is 5-6 times. The procedure for the respiratory muscle training program is as follows: a deep slow inspiration while lips fitted around mouthpiece. Visual feedback is provided to the patient, such as a ball rising to a preset marker, to motivate them during the exercise. The patient is instructed to get the planned flow at preset amount. The patient is asked to maintain breathing in along 2-3 seconds. These guidelines should be followed during respiratory muscle training

Utilizing a pre-session checklist can improve the success rate of using the breather for respiratory muscle training. The following items should be included in the checklist: Check the patient's posture, ensuring that they are in a comfortable crook lying or sitting position, initial easiest resistances by manipulating both dials to one, ensure the patient is using the diaphragmatic breathing technique, as this is crucial for the proper use of the breather, and make sure that the patient secures lips on mouthpiece.

Outcomes

Primary Outcome Measures

arterial blood gases (ABG)
potential of hydrogen( pH )(7.35-7.45). the partial pressure of carbon dioxide in arterial blood.(PaCO2 )(35-45 mmHg). Bicarbonate (HCO3)(22-28 meq/L). arterial oxygen saturation (SaO2) (95-100%). pH (7.35-7.45). PaCO2 (35-45 mmHg). HCO3 (22-28 meq/L). SaO2 (95-100%). . Sample was taken from the radial artery to measure the following parameters6: 7.35-7.45 PH, 35-45 mmHg PaCO2, 22-28 meq/L HCO3, and 95-100% SaO2.
Diaphragmatic excursion
measured diaphragmatic movement for each subject by using the Diaphragmatic ultrasound at 3.5-5MHz probe that aimed at midclavicular line under rib cage aiming posterior 3rd of hemi diaphragm.
Respiratory distress observation scale (RDOS)
evaluate severity and discomfort experienced by patients who are unable to communicate their dyspnea levels during monitoring for palliative sedation therapy . RDOS score of less than 3 indicates that the patient is breathing comfortably, d) an RDOS value ≥3 means respiratory distress that require palliative measures, and e) higher RDOS scores indicate a worsening of the patient's condition.
The National Early Warning Score 2 (NEWS2)
) scoring system for evaluating hospital discharge. It measures six physiological items; respiration and pulse rates, O2 saturation, systolic blood pressure, consciousness level or recent onset confusion, also temperature 9. Each parameter is allocated a score of 0, 1, 2, or 3, elevated values indicate that is far away from normal values. Low risk (aggregate score of 1-4). Low to moderate '3 in a single item' risk. Moderate risk (aggregate score of 5-6). Maximum risk (≥7 value). Critical team of care should perform an emergency assessment, often advice transfer case to a higher dependency unit, and a NEWS2 ≥ 0 i.e., no change, warrants a minimum twice daily check that be a routine monitoring.
Body mass index (BMI )
Ranged from 25 to 29.9 Kg/m2.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2023
Last Updated
September 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06062862
Brief Title
Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia
Official Title
Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Acquired pneumonia is a sever medical condition that addressed as life-threatening issue require intensive care. Medical Breather device permits activating and strengthening of both inspiratory and expiratory musculatures; thus, it could be useful for pneumatic patients. The aim of the study is to investigate breather effect on hospital stay in pneumatic patients.
Detailed Description
Sixty participants diagnosed with acquired pneumonia '30 women, 30 men; selected from chest department of Kasr Alaini Intensive Care Unit (ICU) at Cairo University. They were randomly allocated into equal groups; Group A received respiratory training via incentive spirometer, and traditional chest physiotherapy; and Group B received respiratory training via Breather, and traditional chest physiotherapy. both received 3 session daily/2 weeks. Diaphragmatic excursion, Respiratory Distress Observation Scale, and ICU discharge were assessed pre and post treatment. Careful recruitment of participants based on the study criteria by both ICU resident and PT consultant. Identified inclusive criteria include conscious both genders aged 30- 40 years old with BMI ranged from 25 to5 29.9 Kg/m2 had an acquired pneumonia with a mild hypoxemia (O2 saturation was 90 - 95%). Aware participants whom cooperated through accurate understand and perform instructions. Excluding patients through identified inclusive criteria that if they had a history of any malignant tumors, hearing impairment or mental disorder, auto-immune diseases, a history of any surgical transplantation, unstable hemodynamics, rib fracture, a history of neuromuscular disease, spinal injuries, or BMI > 30 Kg/m2. Also, patients receiving mechanical ventilation, or whom require MV, but contraindicated for rehabilitation i.e., pulmonary emboli were excluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia Hospital Acquired
Keywords
Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A (study group): 30 patients (15 males and 15 females) will receive respiratory training using incentive spirometer in addition to traditional chest physiotherapy, 3 sessions per day, for 2 weeks. Group B (study goup): 30 patients (15 males and 15 females) will receive respiratory training using the breather in addition to traditional chest physiotherapy, 3 sessions per day, for 2 weeks.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Incentive Spirometer group
Arm Type
Active Comparator
Arm Description
The respiratory muscle training program has the following parameters: Duration: 20 minutes per session, Intensity: Clinical adjustment of training intensity based on actual participants' status across session time, holding time, and repetitions. Frequency: 30 per set, with each is 5-6 times. The procedure for the respiratory muscle training program is as follows: a deep slow inspiration while lips fitted around mouthpiece. Visual feedback is provided to the patient, such as a ball rising to a preset marker, to motivate them during the exercise. The patient is instructed to get the planned flow at preset amount. The patient is asked to maintain breathing in along 2-3 seconds. These guidelines should be followed during respiratory muscle training
Arm Title
The Breather Respiratory Muscle Trainer group
Arm Type
Active Comparator
Arm Description
Utilizing a pre-session checklist can improve the success rate of using the breather for respiratory muscle training. The following items should be included in the checklist: Check the patient's posture, ensuring that they are in a comfortable crook lying or sitting position, initial easiest resistances by manipulating both dials to one, ensure the patient is using the diaphragmatic breathing technique, as this is crucial for the proper use of the breather, and make sure that the patient secures lips on mouthpiece.
Intervention Type
Device
Intervention Name(s)
The Incentive Spirometer
Intervention Description
Tri-flow device flow-oriented incentive spirometer .
Intervention Type
Device
Intervention Name(s)
The breather respiratory muscle training device
Intervention Description
The breather respiratory muscle training device which allows for adjustable levels of resistance using easy-to-read dials, which allows to adjust the device to the settings require
Primary Outcome Measure Information:
Title
arterial blood gases (ABG)
Description
potential of hydrogen( pH )(7.35-7.45). the partial pressure of carbon dioxide in arterial blood.(PaCO2 )(35-45 mmHg). Bicarbonate (HCO3)(22-28 meq/L). arterial oxygen saturation (SaO2) (95-100%). pH (7.35-7.45). PaCO2 (35-45 mmHg). HCO3 (22-28 meq/L). SaO2 (95-100%). . Sample was taken from the radial artery to measure the following parameters6: 7.35-7.45 PH, 35-45 mmHg PaCO2, 22-28 meq/L HCO3, and 95-100% SaO2.
Time Frame
Pre and post treatment after 2 weeks
Title
Diaphragmatic excursion
Description
measured diaphragmatic movement for each subject by using the Diaphragmatic ultrasound at 3.5-5MHz probe that aimed at midclavicular line under rib cage aiming posterior 3rd of hemi diaphragm.
Time Frame
Pre and post treatment after 2 weeks
Title
Respiratory distress observation scale (RDOS)
Description
evaluate severity and discomfort experienced by patients who are unable to communicate their dyspnea levels during monitoring for palliative sedation therapy . RDOS score of less than 3 indicates that the patient is breathing comfortably, d) an RDOS value ≥3 means respiratory distress that require palliative measures, and e) higher RDOS scores indicate a worsening of the patient's condition.
Time Frame
Pre and post treatment after 2 weeks
Title
The National Early Warning Score 2 (NEWS2)
Description
) scoring system for evaluating hospital discharge. It measures six physiological items; respiration and pulse rates, O2 saturation, systolic blood pressure, consciousness level or recent onset confusion, also temperature 9. Each parameter is allocated a score of 0, 1, 2, or 3, elevated values indicate that is far away from normal values. Low risk (aggregate score of 1-4). Low to moderate '3 in a single item' risk. Moderate risk (aggregate score of 5-6). Maximum risk (≥7 value). Critical team of care should perform an emergency assessment, often advice transfer case to a higher dependency unit, and a NEWS2 ≥ 0 i.e., no change, warrants a minimum twice daily check that be a routine monitoring.
Time Frame
Pre and post treatment after 2 weeks
Title
Body mass index (BMI )
Description
Ranged from 25 to 29.9 Kg/m2.
Time Frame
Pre and post treatment after 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sixty patients of both sexes from intensive care unit, Cairo University Hospitals. Their age ranged from 30 to 40 years old. Their BMI were from 25 - 29.9 Kg/m2. Their oxygen saturation 90 - 95% (mild hypoxemia) conscious level. Exclusion Criteria: 1. Patient with a history of any malignant tumors. 2. Patients with hearing impairment or mental disorder. 3. Patients with auto-immune diseases. 4. Patients with a history of any surgical transplantation. 5. Patients with hemo-dynamically unstable patients. 6. Patients with rib fracture. 7. Patients with history of neuromuscular disease. 8. Patients with spinal injuries. 9. Patients with BMI > 30 Kg/m2. 10. Patients receiving mechanical ventilation. -
Facility Information:
Facility Name
Faculty of Physical Therapy - Cairo University
City
Cairo
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30955516
Citation
Lanks CW, Musani AI, Hsia DW. Community-acquired Pneumonia and Hospital-acquired Pneumonia. Med Clin North Am. 2019 May;103(3):487-501. doi: 10.1016/j.mcna.2018.12.008. Epub 2019 Mar 7.
Results Reference
background
PubMed Identifier
31585480
Citation
Klompas M. Prevention of Intensive Care Unit-Acquired Pneumonia. Semin Respir Crit Care Med. 2019 Aug;40(4):548-557. doi: 10.1055/s-0039-1695783. Epub 2019 Oct 4.
Results Reference
background

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Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

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