Atelectasis, PostoperativeNCT06702813
Physiological Effects and Safety of Continuous High-frequency Oscillatory Ventilation in ICU Patients
A study testing High-Frequency Oscillatory Ventilation in people with Atelectasis, Postoperative and Hypoxia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Atelectasis, hypoxemia, and ineffective sputum clearance are common problems in ICU patients. Continuous High-Frequency Oscillation (CHFO) is often considered to have a protective effect on the lungs. Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Atelectasis, Postoperative, Hypoxia, Critical Illness
- What is being tested?
- High-Frequency Oscillatory Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 18 and younger than 90 years;
- Admitted to the ICU after December 1, 2024, who are alert, with a GCS of 15, normal comprehension, and able to communicate clearly through speech or writing.
- Patients with atelectasis, who are receiving oxygen therapy, high-flow oxygen, or are on a ventilator via tracheostomy.
- Signed informed consent for MetaNeb treatment.
Who cannot join
- Refusal to participate in the proposed study.
- Age < 10 years;
- Pregnancy;
- Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.
- Participation in another trial within 30 days prior to meeting eligibility criteria;
- Severe chronic respiratory disease requiring long-term oxygen therapy or home mechanical ventilation;
- Pneumothorax. With a clear tracheoesophageal fistula
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200030
Ming Zhong, PhD, 02164001990 ext. 114, zhong.ming@zs-hospital.sh.cn
About this study
Atelectasis, hypoxemia, and ineffective sputum clearance are common problems in ICU patients. Continuous High-Frequency Oscillation (CHFO) is often considered to have a protective effect on the lungs. CHFO provides effective gas exchange at supraphysiological frequencies while minimizing pressure fluctuations, producing tidal volumes smaller than dead space, and adjusting around a continuously expanding pressure to optimize end-expiratory lung volume (EELV), thereby improving lung function by achieving and maintaining lung recruitment. However, the physiological effects and safety of CHFO in awake critically ill patients are still lacking relevant research. The objective of this study is to evaluate the comfort, safety, and efficacy of CHFO in awake critically ill patients.
Read the detailed description
This is an interventional study evaluating the beneficial impact of CHFO (Continuous High Frequency Oscillatory Ventilation) in awake ICU patients with atelectasis on ventilatory function.
This therapeutic study aims to treat patients using the CHFO machine (MetaNeb system). The study involves comparing pulmonary pathophysiological parameters before and after CHFO treatment in awake patients with atelectasis.
The primary outcome is the difference in chest electrical impedance tomography (EIT) measurements taken at the end of CHFO treatment (10 minutes) compared to the baseline value measured at the beginning of the protocol.
The minimum number of subjects to enroll in this study is 45 patients. Intermediate analyses are planned after every 5 patients to reassess the required number of patients.
Baseline data collected at the beginning of the protocol include pulse oximetry and measurements of heart rate and blood pressure. During the treatment, pulse oximetry and measurements of heart rate and blood pressure will be collected. At the end of the treatment, arterial blood gas analysis, heart rate, and blood pressure will be measured. EIT data will be collected at 10 minutes before the start of CHFO, during treatment, and 10 minutes after the treatment. At the end of the treatment, collect patients' subjective ratings of treatment comfort.
- Conditions
- Atelectasis, Postoperative, Hypoxia, Critical Illness
- Being tested
- High-Frequency Oscillatory Ventilation
- Keywords
- HFOV, EIT, atelectasis
- Medical subject headings
- Pulmonary Atelectasis, Hypoxia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency Oscillatory VentilationDevice
Administer 10 minutes of high-frequency oscillatory ventilation in awake ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| CHFO group | Experimental | After checking the availability of the CHFO machine (MetaNeb® system), the inclusion and non-inclusion criteria, the patient is included. The following procedures are performed:
1. installation of an EIT belt in the 4th or 5th intercostal space (Pulmovista® 500, Dräger);
2. continuous recording of digital and analogic data after collecting initial data from the patient within 10 minutes before CHFO treatment, successive 10-minutes CHFO were performed. At the end of the treatment, all the data is collected. Receives: Device: High-Frequency Oscillatory Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EIT
In EIT monitoring, a 16-electrode belt was placed around the chest to record signals. Measurements will be taken at three time points: (1) within 10 minutes before the start of CHFO, (2) during the treatment, and (3) within 10 minutes after its completion.
Measured: Baseline, during the treatment, and at the end of the intervention (10th minute).
Secondary outcomes (3)
SpO2 before, during and after the CHOF treatment
The SpO2 will be measured. Measurements will be taken at three time points: (1) Within 10 minutes before the start of CHFO and (2) During the treatment, and (3)within 10 minutes after its completion.
Measured: Baseline, during the treatment, and at the end of the intervention (10th minute).
Mean arterial pressure
Mean arterial pressure will be measured. Measurements will be taken at three time points: (1) Within 10 minutes before the start of CHFO and (2) During the treatment, and (3)within 10 minutes after its completion.
Measured: Baseline, during the treatment, and at the end of the intervention (10th minute).
Comfort Rating
To have patients rate their comfort level with the treatment using the Numeric Rating Scale (NRS) after the treatment is completed.
Measured: Within 10 minutes after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start19 Nov 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectasis, PostoperativeStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional study evaluating the beneficial impact of continuous high frequency oscillatory ventilation in ICU patients.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702813
- Sponsor's protocol ID
- ZSZZ202411
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects and Safety of Continuous High-frequency Oscillatory Ventilation in ICU Patients
- ClinicalTrials.gov ID
- NCT06702813
- Acronym / sponsor ID
- ZSZZ202411
- Conditions
- Atelectasis, Postoperative, Hypoxia, Critical Illness
- Keywords
- HFOV, EIT, atelectasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 19 Nov 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Nov 2024 (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.
Atelectasis, hypoxemia, and ineffective sputum clearance are common problems in ICU patients. Continuous High-Frequency Oscillation (CHFO) is often considered to have a protective effect on the lungs. CHFO provides effective gas exchange at supraphysiological frequencies while minimizing pressure fluctuations, producing tidal volumes smaller than dead space, and adjusting around a continuously expanding pressure to optimize end-expiratory lung volume (EELV), thereby improving lung function by achieving and maintaining lung recruitment. However, the physiological effects and safety of CHFO in awake critically ill patients are still lacking relevant research. The objective of this study is to evaluate the comfort, safety, and efficacy of CHFO in awake critically ill patients.
Detailed description
This is an interventional study evaluating the beneficial impact of CHFO (Continuous High Frequency Oscillatory Ventilation) in awake ICU patients with atelectasis on ventilatory function.
This therapeutic study aims to treat patients using the CHFO machine (MetaNeb system). The study involves comparing pulmonary pathophysiological parameters before and after CHFO treatment in awake patients with atelectasis.
The primary outcome is the difference in chest electrical impedance tomography (EIT) measurements taken at the end of CHFO treatment (10 minutes) compared to the baseline value measured at the beginning of the protocol.
The minimum number of subjects to enroll in this study is 45 patients. Intermediate analyses are planned after every 5 patients to reassess the required number of patients.
Baseline data collected at the beginning of the protocol include pulse oximetry and measurements of heart rate and blood pressure. During the treatment, pulse oximetry and measurements of heart rate and blood pressure will be collected. At the end of the treatment, arterial blood gas analysis, heart rate, and blood pressure will be measured. EIT data will be collected at 10 minutes before the start of CHFO, during treatment, and 10 minutes after the treatment. At the end of the treatment, collect patients' subjective ratings of treatment comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional study evaluating the beneficial impact of continuous high frequency oscillatory ventilation in ICU patients.
| Arm | Type | Receives |
|---|---|---|
| CHFO group | Experimental | Device: High-Frequency Oscillatory VentilationAfter checking the availability of the CHFO machine (MetaNeb® system), the inclusion and non-inclusion criteria, the patient is included. The following procedures are performed: 1. installation of an EIT belt in the 4th or 5th intercostal space (Pulmovista® 500, Dräger); 2. continuous recording of digital and analogic data after collecting initial data from the patient within 10 minutes before CHFO treatment, successive 10-minutes CHFO were performed. At the end of the treatment, all the data is collected. |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 and younger than 90 years;
- Admitted to the ICU after December 1, 2024, who are alert, with a GCS of 15, normal comprehension, and able to communicate clearly through speech or writing.
- Patients with atelectasis, who are receiving oxygen therapy, high-flow oxygen, or are on a ventilator via tracheostomy.
- Signed informed consent for MetaNeb treatment.
Key exclusion criteria (7 listed)
- Refusal to participate in the proposed study.
- Age < 10 years;
- Pregnancy;
- Significant hemodynamic instability defined as an increase of more than 20% in catecholamine doses in the last hour, despite optimization of blood volume, for a target mean blood pressure between 65 and 75 mmHg.
- Participation in another trial within 30 days prior to meeting eligibility criteria;
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 Oscillatory VentilationAdminister 10 minutes of high-frequency oscillatory ventilation in awake ICU patients. | Device | CHFO group |
Primary outcome
EIT
Time frame: Baseline, during the treatment, and at the end of the intervention (10th minute).
In EIT monitoring, a 16-electrode belt was placed around the chest to record signals. Measurements will be taken at three time points: (1) within 10 minutes before the start of CHFO, (2) during the treatment, and (3) within 10 minutes after its completion.
3 secondary outcomes
SpO2 before, during and after the CHOF treatment
Time frame: Baseline, during the treatment, and at the end of the intervention (10th minute).
Mean arterial pressure
Time frame: Baseline, during the treatment, and at the end of the intervention (10th minute).
Comfort Rating
Time frame: Within 10 minutes after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
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 Oscillatory Ventilation in people with Atelectasis, Postoperative and Hypoxia, run by Shanghai Zhongshan Hospital at 1 site in China.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Nov 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengyu Hao, PhD (02164041990 ext. 13671, janet9yu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EIT (time frame: Baseline, during the treatment, and at the end of the intervention (10th minute).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2024.