Pneumonia Hospital AcquiredNCT06062862
Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia
A study testing The Incentive Spirometer and The breather respiratory muscle training device in people with Pneumonia Hospital Acquired, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Pneumonia Hospital Acquired
- What is being tested?
- The Incentive Spirometer and The breather respiratory muscle training device
- 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
- 30 Apr 2022to 30 Apr 2023
- 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 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pneumonia Hospital Acquired
- Being tested
- The Incentive Spirometer, The breather respiratory muscle training device
- Keywords
- Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Incentive SpirometerDevice
Tri-flow device flow-oriented incentive spirometer .
The breather respiratory muscle training deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| The Incentive Spirometer group | Active comparator | 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 Receives: Device: The Incentive Spirometer |
| The Breather Respiratory Muscle Trainer group | Active comparator | 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. Receives: Device: The breather respiratory muscle training device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre and post treatment after 2 weeks
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.
Measured: Pre and post treatment after 2 weeks
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.
Measured: Pre and post treatment after 2 weeks
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.
Measured: Pre and post treatment after 2 weeks
Body mass index (BMI )
Ranged from 25 to 29.9 Kg/m2.
Measured: Pre and post treatment after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start30 Apr 2022
- Primary completion30 Oct 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia Hospital AcquiredStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Mousa Galeb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062862
- Sponsor's protocol ID
- Hospital Acquired pneumonia
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30955516Klompas 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.
PubMed 31585480
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT06062862
- Acronym / sponsor ID
- Hospital Acquired pneumonia
- Conditions
- Pneumonia Hospital Acquired
- Keywords
- Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Oct 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Incentive Spirometer group | Active comparator | Device: The Incentive SpirometerThe 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 |
| The Breather Respiratory Muscle Trainer group | Active comparator | Device: The breather respiratory muscle training deviceUtilizing 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. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
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 |
|---|---|---|
| The Incentive SpirometerTri-flow device flow-oriented incentive spirometer . | Device | The Incentive Spirometer group |
| The breather respiratory muscle training deviceThe 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 | Device | The Breather Respiratory Muscle Trainer group |
Primary outcome
arterial blood gases (ABG)
Time frame: Pre and post treatment after 2 weeks
* 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
Time frame: Pre and post treatment after 2 weeks
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)
Time frame: Pre and post treatment after 2 weeks
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)
Time frame: Pre and post treatment after 2 weeks
) 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. 1. Low risk (aggregate score of 1-4). 2. Low to moderate '3 in a single item' risk. 3. Moderate risk (aggregate score of 5-6). 4. Maximum risk (≥7 value). Critical team of care should perform an emergency assessment, often advice transfer case to a higher dependency unit, and 5. a NEWS2 ≥ 0 i.e., no change, warrants a minimum twice daily check that be a routine monitoring.
Body mass index (BMI )
Time frame: Pre and post treatment after 2 weeks
Ranged from 25 to 29.9 Kg/m2.
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 2 Oct 2023.
- Background: PubMed 30955516Lanks 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.
- Background: PubMed 31585480Klompas 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Incentive Spirometer and The breather respiratory muscle training device in people with Pneumonia Hospital Acquired, run by Cairo University 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 4 inclusion and 2 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 2 Oct 2023. 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?
arterial blood gases (ABG) (time frame: Pre and post treatment after 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062862, which also lists 2 linked publications.
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 2 Oct 2023.