Clinical trial NCT06062862: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia Hospital Acquired
Keywords: Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Sixty patients of both sexes from intensive care unit, Cairo University Hospitals.
2. Their age ranged from 30 to 40 years old.
3. Their BMI were from 25 - 29.9 Kg/m2.
4. 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.

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Primary outcomes:
measure: arterial blood gases (ABG)
timeFrame: Pre and post treatment after 2 weeks
measure: Diaphragmatic excursion
timeFrame: Pre and post treatment after 2 weeks
measure: Respiratory distress observation scale (RDOS)
timeFrame: Pre and post treatment after 2 weeks
measure: The National Early Warning Score 2 (NEWS2)
timeFrame: Pre and post treatment after 2 weeks
measure: Body mass index (BMI )
timeFrame: Pre and post treatment after 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy - Cairo University
Study officials:
References:
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.
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.