COVID-19HFCWO IN COVIDNCT05705661
INFLUENCE OF HIGH FREQUENCY CHEST WALL OSCILLATION IN HOSPITALIZED PATIENTS WITH COVID-19
A study testing HIGH FREQUENCY CHEST WALL OSCILLATION in people with COVID-19, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- HIGH FREQUENCY CHEST WALL OSCILLATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sixty hospitalized covid-19 patients from both genders their ages will be ranged from 55 - 65 years old.
- Desaturated covid-19 patients with lung fibrosis are diagnosed by the physician and confirmed by chest CT
- Duration of illness ranged from 1 week to 2weeks.
- All patients have resting oxygen saturation (SpO2) from 80 - 92 %
- O2 therapy is delivered via Nasal cannula or face mask.
- 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).
Who cannot join
- Hemodynamically unstable patient
- Patient with pneumothorax (if chest tube is present)
- Asthmatic patient
- Patient with chest deformities
- Patient with pleural effusion
- Patient with diaphragmatic hernia
Show all 11Show fewer
- Patient with cardiac and thoracic surgery
- Mechanically Ventilated and intubated patients.
- Metabolic or cardiovascular diseases.
- Patients have (SpO2) less than 80 %.
- Patient with severe lung fibrosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, This Study Aims To Investigate the Effect of High Frequency Chest Wall Oscillation in Hospitalized Covid-19 Patients.
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:
Read more
- Inflammatory markers: Netrophil to lymphocyte ratio and CRP
- Hemodynamic parameters (Arterial Blood Gases, Heart Rate variability, Respiratory Rate, O2 Saturation).
- 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?
Read the 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.
- Conditions
- COVID-19
- Being tested
- HIGH FREQUENCY CHEST WALL OSCILLATION
- Keywords
- HFCWO, COVID
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIGH FREQUENCY CHEST WALL OSCILLATIONDevice
Also called The (HFCWO) (Comfort Cough II, SOUTH KOREA).
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.
| Study group | Role | What they receive |
|---|---|---|
| The control group (I) | No intervention | 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 | 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). Receives: Device: HIGH FREQUENCY CHEST WALL OSCILLATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gasses (ABG)
Arterial blood gas analysis is a common investigation in emergency departments and intensive care units for monitoring patients with acute respiratory failure. ABG also has some applications in general practice, such as assessing the need for domiciliary oxygen therapy in patients with chronic obstructive pulmonary disease. An arterial blood gas result can help in the assessment of a patient's gas exchange, ventilator control and acid-base balance. (Verma et al., 2010)
Measured: 2 weeks
Netrophil to lymphocyte ratio
The neutrophil-to-lymphocyte ratio (NLR) is an inflammatory marker derived from combining the absolute blood neutrophil and lymphocyte counts, two routinely performed parameters in clinical settings. Recently, studies have reported that NLR levels were higher in more severe patients and were suggested to confer a prognostic value in COVID-19 patients (Lagunas et al.,2020).
Measured: 2 weeks
heart rate variability
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. (Buchhorn et al., 2020).
Measured: 2 weeks
respiratory rate
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 (World Health Organization, 2020).
Resting RR values also contribute to the prognosis of COVID-19 patients as ICU admission and mortality are associated with significantly higher RR values compared to non-ICU patients and survivors (Huang et al., 2020 \& Zhou et al., 2020).
Measured: 2 weeks
O2 saturation
Levels of dyspnea appear to vary significantly amongst patients suffering from COVID-19 ranging from 18.6 to 59%. (Guan et al., 2020). More recently, Li et al (2020) systematic review on 1,994 COVID-19 patients showed an overall percentage of patients experiencing dyspnea was 21.9% in addition. Huang et al. found a prevalence of breathlessness as high as 92% amongst COVID- 19 patients hospitalized in intensive care units versus 37% in non-intensive care units. (Huang et al.,2020).
Measured: 2 weeks
CRP
C-reactive protein) CRP) was an independent risk factor for severe COVID-19. The optimal working point was 38.55 mg/L. This is consistent with previous research showing that hypoalbuminemia, lymphopenia, and CRP more than equal to 40 mg/L were the predictive factors for pneumonia progression to respiratory failure (Ko et al., 2016). Besides, higher CRP has been linked to unfavorable aspects of COVID-19 diseases, such as cardiac injury, and ARDS development, and death. (Terpos et al., 2020).
Measured: 2 weeks
Secondary outcomes (2)
dyspnea questionnaire
The Dyspnea-12 (D-12) Questionnaire is a convenient patient-reported scale for measuring the severity of breathlessness. Breathlessness is quantified by using 12 descriptors to cover both the physical and the psychological dimensions. The D-12 has established its validity and reliability in COPD, asthma, interstitial lung disease, and pulmonary hypertension. (Yorke et al., 2010).
Measured: 2 weeks
Hospital Stay
Severe COVID-19 patients were more likely to present with higher levels of inflammation upon hospital admission.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Jun 2023
- Primary completion1 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Ibrahim Elsayed Elhannony, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705661
- Sponsor's protocol ID
- P.T.REC/012/003890
- Acronym
- HFCWO IN COVID
- Status last verified
- Jul 2024
- First submitted
- 28 Jan 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35703523Chen 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.
PubMed 32007143
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, This Study Aims To Investigate the Effect of High Frequency Chest Wall Oscillation in Hospitalized Covid-19 Patients.
- ClinicalTrials.gov ID
- NCT05705661
- Acronym / sponsor ID
- HFCWO IN COVID / P.T.REC/012/003890
- Conditions
- COVID-19
- Keywords
- HFCWO, COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Inflammatory markers: Netrophil to lymphocyte ratio and CRP
- Hemodynamic parameters (Arterial Blood Gases, Heart Rate variability, Respiratory Rate, O2 Saturation).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The control group (I) | No intervention | –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 | Device: HIGH FREQUENCY CHEST WALL OSCILLATIONThe 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). |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sixty hospitalized covid-19 patients from both genders their ages will be ranged from 55 - 65 years old.
- Desaturated covid-19 patients with lung fibrosis are diagnosed by the physician and confirmed by chest CT
- Duration of illness ranged from 1 week to 2weeks.
- All patients have resting oxygen saturation (SpO2) from 80 - 92 %
- O2 therapy is delivered via Nasal cannula or face mask.
Key exclusion criteria (11 listed)
- Hemodynamically unstable patient
- Patient with pneumothorax (if chest tube is present)
- Asthmatic patient
- Patient with chest deformities
- Patient with pleural effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIGH FREQUENCY CHEST WALL OSCILLATIONAlso: The (HFCWO) (Comfort Cough II, SOUTH KOREA).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. | Device | The study group (II) |
Primary outcome
Arterial blood gasses (ABG)
Time frame: 2 weeks
Arterial blood gas analysis is a common investigation in emergency departments and intensive care units for monitoring patients with acute respiratory failure. ABG also has some applications in general practice, such as assessing the need for domiciliary oxygen therapy in patients with chronic obstructive pulmonary disease. An arterial blood gas result can help in the assessment of a patient's gas exchange, ventilator control and acid-base balance. (Verma et al., 2010)
Netrophil to lymphocyte ratio
Time frame: 2 weeks
The neutrophil-to-lymphocyte ratio (NLR) is an inflammatory marker derived from combining the absolute blood neutrophil and lymphocyte counts, two routinely performed parameters in clinical settings. Recently, studies have reported that NLR levels were higher in more severe patients and were suggested to confer a prognostic value in COVID-19 patients (Lagunas et al.,2020).
heart rate variability
Time frame: 2 weeks
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. (Buchhorn et al., 2020).
respiratory rate
Time frame: 2 weeks
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 (World Health Organization, 2020). Resting RR values also contribute to the prognosis of COVID-19 patients as ICU admission and mortality are associated with significantly higher RR values compared to non-ICU patients and survivors (Huang et al., 2020 \& Zhou et al., 2020).
O2 saturation
Time frame: 2 weeks
Levels of dyspnea appear to vary significantly amongst patients suffering from COVID-19 ranging from 18.6 to 59%. (Guan et al., 2020). More recently, Li et al (2020) systematic review on 1,994 COVID-19 patients showed an overall percentage of patients experiencing dyspnea was 21.9% in addition. Huang et al. found a prevalence of breathlessness as high as 92% amongst COVID- 19 patients hospitalized in intensive care units versus 37% in non-intensive care units. (Huang et al.,2020).
CRP
Time frame: 2 weeks
C-reactive protein) CRP) was an independent risk factor for severe COVID-19. The optimal working point was 38.55 mg/L. This is consistent with previous research showing that hypoalbuminemia, lymphopenia, and CRP more than equal to 40 mg/L were the predictive factors for pneumonia progression to respiratory failure (Ko et al., 2016). Besides, higher CRP has been linked to unfavorable aspects of COVID-19 diseases, such as cardiac injury, and ARDS development, and death. (Terpos et al., 2020).
2 secondary outcomes
dyspnea questionnaire
Time frame: 2 weeks
Hospital Stay
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 35703523Celik 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.
- Background: PubMed 32007143Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIGH FREQUENCY CHEST WALL OSCILLATION in people with COVID-19, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gasses (ABG) (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05705661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.