INFLUENCE OF HIGH FREQUENCY CHEST WALL OSCILLATION IN HOSPITALIZED PATIENTS WITH COVID-19 (HFCWO IN COVID)

Cairo University (CU)

Status: Completed

Conditions: COVID-19

Treatments: Device: HIGH FREQUENCY CHEST WALL OSCILLATION

Study type: Interventional

Funder types: Other

Identifiers

NCT05705661

P.T.REC/012/003890

Details and patient eligibility

About

INFLUENCE OF HIGH FREQUENCY CHEST WALL OSCILLATION IN HOSPITALIZED PATIENTS WITH COVID-19

The purpose of this Interventional study is to investigate the effect of high frequency chest wall oscillation in hospitalized COVID-19 patients on:

1. Inflammatory markers: Netrophil to lymphocyte ratio and CRP
2. Hemodynamic parameters (Arterial Blood Gases, Heart Rate variability, Respiratory Rate, O2 Saturation).
3. Dyspnea, time needed for oxygen weaning, Mortality Rate and Hospital stay period.

Hypotheses :

This Interventional study will test the following Null hypothesis:

• HFCWO will not have an effect in hospitalized COVID-19 patients regarding Arterial Blood Gases, CRP, Dyspnea, Heart Rate variability, Respiratory Rate, O2 Saturation, time needed for Oxygen Weaning, Mortality Rate and Hospital Stay Period.Research Question:
• Is there a significant effect of high frequency chest wall oscillation (HFCWO) in Hospitalized COVID-19 Patients?

Full description

Novel coronavirus disease 2019 (COVID-19) infections, declared by the World Health Organization (WHO) as a pandemic, had unprecedented global effects on people's daily activities and way of life.

High-frequency chest wall oscillation (HFCWO) have been shown to be effective at loosening and removing airway mucus in hospitalized people. Mucus weight was greater after HFCWO than after traditional airway clearance interventions involving postural drainage and manual percussion and vibration techniques.

Earlier diagnosis of COVID-19 may be facilitated by heart rate (HR) and heart rate variability (HRV) monitoring. HR and HRV parameters could not only help to detect COVID-19 in a timely manner but could also help to identify patients at risk for cardiovascular/pulmonary complications. Additionally, HRV and HR parameters may help to assess the course of the disease.

The World Health Organization indicates that a resting value of RR > 30 breaths/min is a critical sign for the diagnosis of severe pneumonia in adults, while the cut-off value for children varies according to age.

Enrollment: 70 patients

Sex: All

Ages: 55 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Sixty hospitalized covid-19 patients from both genders their ages will be ranged from 55 - 65 years old.
2. Desaturated covid-19 patients with lung fibrosis are diagnosed by the physician and confirmed by chest CT
3. Duration of illness ranged from 1 week to 2weeks.
4. All patients have resting oxygen saturation (SpO2) from 80 - 92 %
5. O2 therapy is delivered via Nasal cannula or face mask.
6. All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients (Appendix I).

Exclusion criteria

1. Hemodynamically unstable patient
2. Patient with pneumothorax (if chest tube is present)
3. Asthmatic patient
4. Patient with chest deformities
5. Patient with pleural effusion
6. Patient with diaphragmatic hernia
7. Patient with cardiac and thoracic surgery
8. Mechanically Ventilated and intubated patients.
9. Metabolic or cardiovascular diseases.
10. Patients have (SpO2) less than 80 %.
11. Patient with severe lung fibrosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

The control group (I)

No Intervention group

Description:

The control group (I): The participants will follow the traditional pulmonary rehabilitation program including (active cycle of breathing technique, breathing control, deep breathing exercises, huffing). The session duration will be between 30 min twice/day for 15 days as guided by subject fatigue and comfort. (According to Borg scale of dyspnea for monitoring).

The study group (II)

Active Comparator group

Description:

The study group (II): The participants will receive active cycle of breathing technique, breathing control, deep breathing exercises (15 min) in addition to (HFCWO); the patient position will be in a semi-recline position, with wrapped vest around the chest. The (HFCWO) protocol included 3-5 cycles, with a pressure range of +10 to +40 IP cmH2O and will be adjusted according to the patient age, number of secretions, tolerance of patients, and chest auscultation every session. The numbers of total sets will be 3-5 with a duration of 15 min, daily, for two sessions / day , time range according to the ability of the patient. (Çelik et al., 2021).

Treatment:

Device: HIGH FREQUENCY CHEST WALL OSCILLATION