Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

Pneumonia Hospital Acquired Clinical Trial

Official title:

Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06062862
• Other study ID #: Hospital Acquired pneumonia
• Status: Completed
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The aim of the study is to investigate breather effect on hospital stay in pneumatic patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 40 Years

Eligibility

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.

-

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia Hospital Acquired

Intervention

Device:
• The Incentive Spirometer
Tri-flow device flow-oriented incentive spirometer .
• The breather respiratory muscle training device
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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre and post treatment after 2 weeks
Primary	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.	Pre and post treatment after 2 weeks
Primary	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.	Pre and post treatment after 2 weeks
Primary	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.	Pre and post treatment after 2 weeks
Primary	Body mass index (BMI )	Ranged from 25 to 29.9 Kg/m2.	Pre and post treatment after 2 weeks