Clinical trial NCT05705661: INFLUENCE OF HIGH FREQUENCY CHEST WALL OSCILLATION IN HOSPITALIZED PATIENTS WITH COVID-19
Official title: Randomized, This Study Aims To Investigate the Effect of High Frequency Chest Wall Oscillation in Hospitalized Covid-19 Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: HFCWO
COVID
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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?

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Arterial blood gasses (ABG)
timeFrame: 2 weeks
measure: Netrophil to lymphocyte ratio
timeFrame: 2 weeks
measure: heart rate variability
timeFrame: 2 weeks
measure: respiratory rate
timeFrame: 2 weeks
measure: O2 saturation
timeFrame: 2 weeks
measure: CRP
timeFrame: 2 weeks
Secondary outcomes:
measure: dyspnea questionnaire
timeFrame: 2 weeks
measure: Hospital Stay
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hadeel Elhannony
state: القاهرة
Study officials:
References:
citation: Celik M, Yayik AM, Kerget B, Kerget F, Doymus O, Aksakal A, Ozmen S, Aslan MH, Uzun Y. High-Frequency Chest Wall Oscillation in Patients with COVID-19: A Pilot Feasibility Study. Eurasian J Med. 2022 Jun;54(2):150-156. doi: 10.5152/eurasianjmed.2022.21048.
citation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.