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Completed

NCT Number: NCT06062862

Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

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.

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Key information

Conditions

Pneumonia Hospital Acquired Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy - Cairo University

Cairo, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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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Treatment and study plan

The Incentive Spirometer

Device

Tri-flow device flow-oriented incentive spirometer .

The breather respiratory muscle training device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

    • 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.

  5. Body mass index (BMI )

    Time frame: Pre and post treatment after 2 weeks

    Ranged from 25 to 29.9 Kg/m2.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 2, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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