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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-09-15

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A. Subject selection:

After calculating sample size, sixty hospitalized Covid-19 Patients will be assigned into two equal matched groups randomly:

Group I (Control): will consist of 30 hospitalized covid-19 patients with (nasal cannula/face mask) who will receive traditional respiratory techniques (breathing ex.) plus their traditional medications.

Group II (Study): will consist of 30 hospitalized covid-19 patients with (nasal cannula/ face mask) who will receive high frequency chest wall oscillation in addition to breathing exercise techniques plus their traditional medications.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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The control group (I)

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

The study group (II)

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).

Group Type ACTIVE_COMPARATOR

HIGH FREQUENCY CHEST WALL OSCILLATION

Intervention Type DEVICE

The HFCWO device used a triangular wave form which increases the airflow velocity more than other devices. Therefore, clearing sticky airway mucus and alveolar exudates and maintaining airway patency has become currently the most urgent issue in the ventilatory management of patients with severe COVID-19.

Interventions

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HIGH FREQUENCY CHEST WALL OSCILLATION

The HFCWO device used a triangular wave form which increases the airflow velocity more than other devices. Therefore, clearing sticky airway mucus and alveolar exudates and maintaining airway patency has become currently the most urgent issue in the ventilatory management of patients with severe COVID-19.

Intervention Type DEVICE

Other Intervention Names

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The (HFCWO) (Comfort Cough II, SOUTH KOREA).

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes