Mechanically Ventilated PatientsNCT06791798
Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients
A study testing Ventilator Hyperinflation, Vibrocompression and Traditional Chest Physical Therapy Program in people with Mechanically Ventilated Patients and Lung Compliance, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the current study is to compare the effects of ventilator hyperinflation and vibrocompression on lung compliance in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Mechanically Ventilated Patients, Lung Compliance, Airway Clearance Impairment
- What is being tested?
- Ventilator Hyperinflation, Vibrocompression and Traditional Chest Physical Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to May 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 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eighty-one mechanically ventilated patients more than 48 hours up to 7 days
- Their ages range from 35 to 55 years old.
- Medical stability (mean arterial pressure > 60 < 110, systolic blood pressure > 80, diastolic blood pressure > 60, fraction of inspired oxygen < 60, positive end expiratory pressure (PEEP) <10)
Who cannot join
- Patients will be excluded if they have the following conditions or diseases:
- Unstable hemodynamics
- Fraction of inspired oxygen (FiO2) ≥ 0.6
- PEEP ≥ 10 cmH2O
- undrained pneumothorax and hemothorax or subcutaneous emphysema
- Pulmonary pathology (e.g., acute respiratory distress syndrome, exacerbation of chronic obstructive pulmonary disease, and acute pulmonary edema)
Show all 10Show fewer
- Unstable neurological problems (raised intracranial pressure).
- Lung Cancer
- Recent/unhealed rib fracture
- Any disease obstructs our study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Ventilator Hyperinflation Versus Vibrocompression on Lung Compliance in Mechanically Ventilated Patients
The aim of the current study is to compare the effects of ventilator hyperinflation and vibrocompression on lung compliance in mechanically ventilated patients.
Read the detailed description
Lower respiratory infections remained the world's most deadly communicable disease, ranked as the 4th leading cause of death.
The aim of mechanical ventilation is to reduce the ventilatory work and maintain gas exchange, but it also has deleterious effects on mucociliary transport and coughing ability. These effects provoke the stasis of secretions in the airways and bronchial obstruction, with hypoventilation, atelectasis, and consequent hypoxemia. This set of factors also favors microorganism multiplication and, thus, an increased incidence of ventilator-associated pneumonia (VAP), impaired gas exchange, pulmonary infection and fibrosis, and progressive reduction of lung compliance. To reverse or reduce these deleterious effects, bronchial hygiene techniques are used by physical therapists in several ICUs around the world. Among these techniques, tracheal aspiration, vibrocompression (VB), and hyperinflation with mechanical ventilation are commonly employed.
Lung compliance is inversely proportional to elastance. This elastic resistance is due to the elastic property of lung tissue or parenchyma and the surface elastic force. Any changes occurring to these forces could lead to changes in compliance. Compliance determines 65% of the work of breathing. If the lung has low compliance, it requires more work from breathing muscles to inflate the lungs. In specific pathologies, continuous monitoring of the lung compliance curve is useful to understand the condition's progression and to decide on therapeutic settings needed for ventilator management So, the current study will help to determine the effects of ventilator hyperinflation and vibrocompression on lung compliance and sputum production in mechanically ventilated patients.
- Being tested
- Ventilator Hyperinflation, Vibrocompression, Traditional Chest Physical Therapy Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator HyperinflationOther
In ventilator hyperinflation volume control mode, the ventilator will be set to eight breaths per minute, and the tidal volume will be increased to deliver hyperinflation breaths that are 15 ml/kg, as will be calculated using the predicted body weight. Tidal volume will be increased in 150-ml increments until a peak airway pressure of 40 cmH2O is achieved. Once this pressure is reached, eight mechanical breaths will be delivered to the patient. After this, the ventilator will be reset to pretreatment variables, and the patient will be rested for 30 s. The sequence will be repeated. The treatment will consist of five sets of eight ventilator hyperinflation breaths.
VibrocompressionOther
Vibrocompression will be performed by the physical therapist to produce vibration and will be combined with compression of the patient's chest in the expiratory phase. Every vibrocompression will be interrupted at the end of each expiratory phase to allow free inspiration.
Traditional Chest Physical Therapy ProgramOther
Percussion, Postural Drainage, and Suction
| Study group | Role | What they receive |
|---|---|---|
| Study Group (A) | Active comparator | The patients in the study group (A) will be treated with ventilator hyperinflation in addition to a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day. Receives: Other: Ventilator Hyperinflation; Other: Traditional Chest Physical Therapy Program |
| Study Group (B) | Active comparator | The patients in the study group (B) will be treated with vibrocompression in addition to a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day. Receives: Other: Vibrocompression; Other: Traditional Chest Physical Therapy Program |
| Control Group (C) | Active comparator | The patients in the control group (C) will be treated with a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day. Receives: Other: Traditional Chest Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Compliance
Static compliance (ml/cmH2O).
Measured: Before, after treatment at Day 1 and Day 4
Airway Resistance
Airway Resistance (cmH2O/l/s).
Measured: Before, after treatment at Day 1 and Day 4
Sputum Volume in ml
Airway suction will be carried out immediately after treatment or during treatment if indicated and will be measured as sputum volume in ml.
Measured: Immediately after treatment at Day 1 and Day 4
Peak Expiratory Flow and Peak Inspiratory Flow
Peak Expiratory Flow (l/min) and Peak Inspiratory Flow (l/min)
Measured: Before, after treatment at Day 1 and Day 4
Secondary outcomes (1)
Oxygen Saturation (SPO2)
Peripheral oxygen saturation (SPO2) in percentage
Measured: Before, after treatment at Day 1 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Hassan Mohamed Hussien, Cairo University
- Investigators
- Nadia H Mohamed, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791798
- Sponsor's protocol ID
- P.T.REC/012/005560
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ventilator Hyperinflation Versus Vibrocompression on Lung Compliance in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06791798
- Acronym / sponsor ID
- P.T.REC/012/005560
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
The aim of the current study is to compare the effects of ventilator hyperinflation and vibrocompression on lung compliance in mechanically ventilated patients.
Detailed description
Lower respiratory infections remained the world's most deadly communicable disease, ranked as the 4th leading cause of death.
The aim of mechanical ventilation is to reduce the ventilatory work and maintain gas exchange, but it also has deleterious effects on mucociliary transport and coughing ability. These effects provoke the stasis of secretions in the airways and bronchial obstruction, with hypoventilation, atelectasis, and consequent hypoxemia. This set of factors also favors microorganism multiplication and, thus, an increased incidence of ventilator-associated pneumonia (VAP), impaired gas exchange, pulmonary infection and fibrosis, and progressive reduction of lung compliance. To reverse or reduce these deleterious effects, bronchial hygiene techniques are used by physical therapists in several ICUs around the world. Among these techniques, tracheal aspiration, vibrocompression (VB), and hyperinflation with mechanical ventilation are commonly employed.
Lung compliance is inversely proportional to elastance. This elastic resistance is due to the elastic property of lung tissue or parenchyma and the surface elastic force. Any changes occurring to these forces could lead to changes in compliance. Compliance determines 65% of the work of breathing. If the lung has low compliance, it requires more work from breathing muscles to inflate the lungs. In specific pathologies, continuous monitoring of the lung compliance curve is useful to understand the condition's progression and to decide on therapeutic settings needed for ventilator management So, the current study will help to determine the effects of ventilator hyperinflation and vibrocompression on lung compliance and sputum production in mechanically ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group (A) | Active comparator | Other: Ventilator Hyperinflation, Other: Traditional Chest Physical Therapy ProgramThe patients in the study group (A) will be treated with ventilator hyperinflation in addition to a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day. |
| Study Group (B) | Active comparator | Other: Vibrocompression, Other: Traditional Chest Physical Therapy ProgramThe patients in the study group (B) will be treated with vibrocompression in addition to a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day. |
| Control Group (C) | Active comparator | Other: Traditional Chest Physical Therapy ProgramThe patients in the control group (C) will be treated with a traditional chest physical therapy program (percussion, postural drainage, and suction) for 4 successive sessions at a rate of one session per day. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Eighty-one mechanically ventilated patients more than 48 hours up to 7 days
- Their ages range from 35 to 55 years old.
- Medical stability (mean arterial pressure > 60 < 110, systolic blood pressure > 80, diastolic blood pressure > 60, fraction of inspired oxygen < 60, positive end expiratory pressure (PEEP) <10)
Key exclusion criteria (10 listed)
- Unstable hemodynamics
- Fraction of inspired oxygen (FiO2) ≥ 0.6
- PEEP ≥ 10 cmH2O
- undrained pneumothorax and hemothorax or subcutaneous emphysema
- Pulmonary pathology (e.g., acute respiratory distress syndrome, exacerbation of chronic obstructive pulmonary disease, and acute pulmonary edema)
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 |
|---|---|---|
| Ventilator HyperinflationIn ventilator hyperinflation volume control mode, the ventilator will be set to eight breaths per minute, and the tidal volume will be increased to deliver hyperinflation breaths that are 15 ml/kg, as will be calculated using the predicted body weight. Tidal volume will be increased in 150-ml increments until a peak airway pressure of 40 cmH2O is achieved. Once this pressure is reached, eight mechanical breaths will be delivered to the patient. After this, the ventilator will be reset to pretreatment variables, and the patient will be rested for 30 s. The sequence will be repeated. The treatment will consist of five sets of eight ventilator hyperinflation breaths. | Other | Study Group (A) |
| VibrocompressionVibrocompression will be performed by the physical therapist to produce vibration and will be combined with compression of the patient's chest in the expiratory phase. Every vibrocompression will be interrupted at the end of each expiratory phase to allow free inspiration. | Other | Study Group (B) |
| Traditional Chest Physical Therapy ProgramPercussion, Postural Drainage, and Suction | Other | Control Group (C), Study Group (A), Study Group (B) |
Primary outcome
Static Compliance
Time frame: Before, after treatment at Day 1 and Day 4
Static compliance (ml/cmH2O).
Airway Resistance
Time frame: Before, after treatment at Day 1 and Day 4
Airway Resistance (cmH2O/l/s).
Sputum Volume in ml
Time frame: Immediately after treatment at Day 1 and Day 4
Airway suction will be carried out immediately after treatment or during treatment if indicated and will be measured as sputum volume in ml.
Peak Expiratory Flow and Peak Inspiratory Flow
Time frame: Before, after treatment at Day 1 and Day 4
Peak Expiratory Flow (l/min) and Peak Inspiratory Flow (l/min)
1 secondary outcome
Oxygen Saturation (SPO2)
Time frame: Before, after treatment at Day 1 and Day 4
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 7 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Nadia H Mohamed, MSc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator Hyperinflation, Vibrocompression and Traditional Chest Physical Therapy Program in people with Mechanically Ventilated Patients and Lung Compliance, 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 3 inclusion and 10 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 7 Feb 2025. 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?
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 Nadia H Mohamed, MSc (+201148709641/+201220058803, nadia93hassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Compliance (time frame: Before, after treatment at Day 1 and Day 4). The study lists 4 primary outcomes in all. 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 7 Feb 2025.