Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia

NCT06062862 | Completed

• 1 other identifier: Hospital Acquired pneumonia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia Hospital Acquired

Keywords

Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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. 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.

  Pre and post treatment after 2 weeks

• Body mass index (BMI )

  Ranged from 25 to 29.9 Kg/m2.

  Pre and post treatment after 2 weeks

Study Arms (2)

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

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.

Device: The breather respiratory muscle training device

Interventions

The Incentive Spirometer DEVICE

Tri-flow device flow-oriented incentive spirometer .

The Incentive Spirometer group

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

The Breather Respiratory Muscle Trainer group

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Cairo, 11517, Egypt

Location

Related Publications (2)

• 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.

  PMID: 30955516 BACKGROUND

• 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.

  PMID: 31585480 BACKGROUND

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at the Department of Physical Therapy for Cardiovascular /Respiratory Disorders and Geriatrics Faculty of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 2, 2023
• Study Start: April 30, 2022
• Primary Completion: October 30, 2022
• Study Completion: April 30, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

EG (1)