Mechanical Ventilation ComplicationNCT05128552
Effect of Lung Volume Recruitment Technique After Extubation
A study testing Lung volume recruitment technique and Traditional chest physiotherapy in people with Mechanical Ventilation Complication and Diaphragm Issues, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to investigate the effect of the LVR technique on cough ineffectiveness, to determine its benefit as a simple, safe, and inexpensive cough augmentation technique, and to determine how much the LVR method, for augmenting CPF, is useful in enhancing the success of extubation and reducing the… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Mechanical Ventilation Complication, Diaphragm Issues, Cough
- What is being tested?
- Lung volume recruitment technique and Traditional chest physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2020to 1 Oct 2021
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty to sixty years old patients had undergone mechanical ventilation for ≥ 48 hours in a controlled mode and had been weaned after a successful spontaneous breathing trial with suboptimal or poor CPF < 270 L/min.
- Patients were able to assume a sitting position.
- All participants were aware, cooperative, competent, able to comply with treatment, and able to understand and follow instructions.
Who cannot join
- Presence of significant or active hemoptysis, untreated or recent pneumothorax, bullous emphysema, lung trauma, or recent lobectomy.
- Patients with comorbidities interfering and compromising the success of either weaning or extubation, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or acute coronary syndrome.
- Patients who had originally inadequate training performance of the respiratory muscle such as those having NMD, i.e., myopathy or neuropathy.
- Impaired consciousness/inability to communicate.
- Patients who had a neurological deficit resulted in bulbar affection.
- Patients with indications for MV, but contraindicated for physical therapy like pulmonary embolism.
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- Patients who had undergone tracheotomy before extubation also were excluded or who had experienced less than 24 hours of mechanical ventilation.
- Patients with unstable hemodynamics or cardiac instability.
- Current undrained pleural effusion or previous pneumothorax or barotrauma.
- Uncontrolled severe COPD, poorly controlled asthma, and severe bronchospasm.
- Patients with visual or/and auditory problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy Cairo University
Cairo, Giza Governorate
About this study
Official title: Effect of Lung Volume Recruitment Technique on Cough Efficacy in Postextubated Patients With Ineffective Cough
This study was conducted to investigate the effect of the LVR technique on cough ineffectiveness, to determine its benefit as a simple, safe, and inexpensive cough augmentation technique, and to determine how much the LVR method, for augmenting CPF, is useful in enhancing the success of extubation and reducing the rate of reintubation.
Read the detailed description
An effective cough is so vital in protecting against respiratory tract infections, so the importance of an intact cough mechanism is reflected in the occurrence of pulmonary problems which are the most common cause of hospital admission in people with respiratory muscle weakness who are unable to cough effectively. Ineffective cough results in a tendency to retain bronchial secretions and an increased risk of pulmonary complications, such as frequent or recurrent pneumonia, atelectasis, and infectious respiratory problems.
Cough flow testing (expiratory flows testing) is useful as a monitoring or diagnostic tool in clinical practice and research. Both peak expiratory flows (PEF) and cough peak flows (CPF) have been described as useful clinical measures of respiratory muscle function and cough effectiveness. Cough peak flow (CPF) gives an important measure of the cough strength which determines the effectiveness of cough. It is the maximum expiratory flow recorded immediately following the opening of the glottis during normal cough. Cough effectiveness is suboptimal when cough peak flow (CPF) is less than 270 L/min.
Mechanical Ventilation "MV" has deleterious effects caused by the endotracheal intubation, including changes in mucociliary clearance and inhibition of the coughing mechanism which, in turn, favor areas of hypoventilation and atelectasis, thus increasing the risk of ventilator-associated pneumonia. Respiratory compromise due to recurrent atelectasis, inability to clear secretions, and respiratory infections also increase morbidity and mortality. Prolonged MV results in respiratory muscle dysfunction shown in diaphragmatic atrophy and contractile dysfunction (ic., Ventilator-induced diaphragmatic dysfunction "VIDD") affecting the ability of the person to cough effectively. Indeed, the onset of VIDD in both animals and humans is rapid as significant diaphragmatic atrophy and contractile dysfunction occur within the first 24 - 48 h of MV. Although suctioning of secretions from the trachea to remove tracheobronchial and upper airway secretions is the standard of care, this method is ineffective for clearing peripheral airways and basal retained secretions.
The clinical practice guides referred to patients with respiratory muscles weakness like after prolonged MV and in neuromuscular diseases recommend the usage of cough augmentation and mucociliary clearance techniques in patients with CPF < 4.5 L/s (270 L'min) and using such techniques continuously in patients with CPF < 2.7 L/s (160 L/min). Cough augmentation techniques such as LVR are supposed to be used to reinforce cough effectiveness, particularly for patients with prolonged mechanical ventilation. So, the importance and strength of this study are to assess the effects of the LVR technique as a cough augmentation mean on CPF of post-extubated patients with an ineffective cough which can cause risky respiratory complications may lead to death in confronting to effects of traditional chest physiotherapy and suctioning and therefore, their therapy or management program can be precisely and appropriately planned. Moreover, the identification of effective, safe measures to optimize cough efficacy is, therefore, key to improving quality of life and minimizing morbidity \& mortality rates in those patients. Additionally, as a secondary purpose to determine how much the LVR method, for augmenting CPF. is useful in enhancing the success of extubation and reducing the rate of re-intubation that indicated if extubation failure occurred.
- Conditions
- Mechanical Ventilation Complication, Diaphragm Issues, Cough, Ineffective Airway Clearance, Intensive Care Unit Acquired Weakness
- Being tested
- Lung volume recruitment technique, Traditional chest physiotherapy
- Keywords
- Cough peak flow, Lung volume recruitment, Air stacking, Cough efficacy, Post extubated patient, Respiratory therapy, Intensive care unit, Mechanical ventilation
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volume recruitment techniqueDevice
Also called Air stacking or breath stacking technique
A self inflating Ambu bag with one way valve , augmentation volume of air within 3 to 4 successive breaths and holding few seconds then coughing
Traditional chest physiotherapyOther
Positioning of the patient according the drainage position for each lobe of each lung and applying airway hygiene techniques such as percussion and vibration
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Twenty-five patients who received traditional chest physiotherapy and LVR technique for 30-45 minutes for successive 4 Days after extubation Receives: Device: Lung volume recruitment technique; Other: Traditional chest physiotherapy |
| Control group | Active comparator | Twenty-five patients who received only traditional chest physiotherapy for 30 minutes at least for successive 4 Days after extubation Receives: Other: Traditional chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough peak flow rate
The maximum expiratory flow produced immediately after the glottis opens during a physiological cough
Measured: "Day 4"
Peak expiratory flow rate
The maximum rate at which the air can be expired after a deep inspiration
Measured: "Day 4"
Oxygen Saturation
The percentage that represents how haemoglobin are saturated with oxygen atoms
Measured: "Day 4"
Secondary outcomes (1)
Extubation's success
The patient pass first 48 - 72 hours after extubation alive and doesn't need to be reintubated
Measured: "Day 4"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start15 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
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 Mechanical Ventilation ComplicationStudies 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
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud El-Sayed Abduh Ragab, Cairo University
- Investigators
- Mahmoud S. Ragab, Bsc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128552
- Sponsor's protocol ID
- LVR in ICU
- Status last verified
- Nov 2021
- First submitted
- 29 Oct 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.
PubMed 28075489Rose L, Adhikari NK, Poon J, Leasa D, McKim DA; CANuVENT Group. Cough Augmentation Techniques in the Critically Ill: A Canadian National Survey. Respir Care. 2016 Oct;61(10):1360-8. doi: 10.4187/respcare.04775. Epub 2016 Sep 13.
PubMed 27624630
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lung Volume Recruitment Technique on Cough Efficacy in Postextubated Patients With Ineffective Cough
- ClinicalTrials.gov ID
- NCT05128552
- Acronym / sponsor ID
- LVR in ICU
- Conditions
- Mechanical Ventilation Complication, Diaphragm Issues, Cough, Ineffective Airway Clearance, Intensive Care Unit Acquired Weakness
- Keywords
- Cough peak flow, Lung volume recruitment, Air stacking, Cough efficacy, Post extubated patient, Respiratory therapy, Intensive care unit, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 22 Nov 2021 (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.
This study was conducted to investigate the effect of the LVR technique on cough ineffectiveness, to determine its benefit as a simple, safe, and inexpensive cough augmentation technique, and to determine how much the LVR method, for augmenting CPF, is useful in enhancing the success of extubation and reducing the rate of reintubation.
Detailed description
An effective cough is so vital in protecting against respiratory tract infections, so the importance of an intact cough mechanism is reflected in the occurrence of pulmonary problems which are the most common cause of hospital admission in people with respiratory muscle weakness who are unable to cough effectively. Ineffective cough results in a tendency to retain bronchial secretions and an increased risk of pulmonary complications, such as frequent or recurrent pneumonia, atelectasis, and infectious respiratory problems.
Cough flow testing (expiratory flows testing) is useful as a monitoring or diagnostic tool in clinical practice and research. Both peak expiratory flows (PEF) and cough peak flows (CPF) have been described as useful clinical measures of respiratory muscle function and cough effectiveness. Cough peak flow (CPF) gives an important measure of the cough strength which determines the effectiveness of cough. It is the maximum expiratory flow recorded immediately following the opening of the glottis during normal cough. Cough effectiveness is suboptimal when cough peak flow (CPF) is less than 270 L/min.
Mechanical Ventilation "MV" has deleterious effects caused by the endotracheal intubation, including changes in mucociliary clearance and inhibition of the coughing mechanism which, in turn, favor areas of hypoventilation and atelectasis, thus increasing the risk of ventilator-associated pneumonia. Respiratory compromise due to recurrent atelectasis, inability to clear secretions, and respiratory infections also increase morbidity and mortality. Prolonged MV results in respiratory muscle dysfunction shown in diaphragmatic atrophy and contractile dysfunction (ic., Ventilator-induced diaphragmatic dysfunction "VIDD") affecting the ability of the person to cough effectively. Indeed, the onset of VIDD in both animals and humans is rapid as significant diaphragmatic atrophy and contractile dysfunction occur within the first 24 - 48 h of MV. Although suctioning of secretions from the trachea to remove tracheobronchial and upper airway secretions is the standard of care, this method is ineffective for clearing peripheral airways and basal retained secretions.
The clinical practice guides referred to patients with respiratory muscles weakness like after prolonged MV and in neuromuscular diseases recommend the usage of cough augmentation and mucociliary clearance techniques in patients with CPF < 4.5 L/s (270 L'min) and using such techniques continuously in patients with CPF < 2.7 L/s (160 L/min). Cough augmentation techniques such as LVR are supposed to be used to reinforce cough effectiveness, particularly for patients with prolonged mechanical ventilation. So, the importance and strength of this study are to assess the effects of the LVR technique as a cough augmentation mean on CPF of post-extubated patients with an ineffective cough which can cause risky respiratory complications may lead to death in confronting to effects of traditional chest physiotherapy and suctioning and therefore, their therapy or management program can be precisely and appropriately planned. Moreover, the identification of effective, safe measures to optimize cough efficacy is, therefore, key to improving quality of life and minimizing morbidity \& mortality rates in those patients. Additionally, as a secondary purpose to determine how much the LVR method, for augmenting CPF. is useful in enhancing the success of extubation and reducing the rate of re-intubation that indicated if extubation failure occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Lung volume recruitment technique, Other: Traditional chest physiotherapyTwenty-five patients who received traditional chest physiotherapy and LVR technique for 30-45 minutes for successive 4 Days after extubation |
| Control group | Active comparator | Other: Traditional chest physiotherapyTwenty-five patients who received only traditional chest physiotherapy for 30 minutes at least for successive 4 Days after extubation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Forty to sixty years old patients had undergone mechanical ventilation for ≥ 48 hours in a controlled mode and had been weaned after a successful spontaneous breathing trial with suboptimal or poor CPF < 270 L/min.
- Patients were able to assume a sitting position.
- All participants were aware, cooperative, competent, able to comply with treatment, and able to understand and follow instructions.
Key exclusion criteria (11 listed)
- Presence of significant or active hemoptysis, untreated or recent pneumothorax, bullous emphysema, lung trauma, or recent lobectomy.
- Patients with comorbidities interfering and compromising the success of either weaning or extubation, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or acute coronary syndrome.
- Patients who had originally inadequate training performance of the respiratory muscle such as those having NMD, i.e., myopathy or neuropathy.
- Impaired consciousness/inability to communicate.
- Patients who had a neurological deficit resulted in bulbar affection.
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 |
|---|---|---|
| Lung volume recruitment techniqueAlso: Air stacking or breath stacking techniqueA self inflating Ambu bag with one way valve , augmentation volume of air within 3 to 4 successive breaths and holding few seconds then coughing | Device | Study group |
| Traditional chest physiotherapyPositioning of the patient according the drainage position for each lobe of each lung and applying airway hygiene techniques such as percussion and vibration | Other | Control group, Study group |
Primary outcome
Cough peak flow rate
Time frame: "Day 4"
The maximum expiratory flow produced immediately after the glottis opens during a physiological cough
Peak expiratory flow rate
Time frame: "Day 4"
The maximum rate at which the air can be expired after a deep inspiration
Oxygen Saturation
Time frame: "Day 4"
The percentage that represents how haemoglobin are saturated with oxygen atoms
1 secondary outcome
Extubation's success
Time frame: "Day 4"
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 22 Nov 2021.
- Background: PubMed 28075489Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.
- Background: PubMed 27624630Rose L, Adhikari NK, Poon J, Leasa D, McKim DA; CANuVENT Group. Cough Augmentation Techniques in the Critically Ill: A Canadian National Survey. Respir Care. 2016 Oct;61(10):1360-8. doi: 10.4187/respcare.04775. Epub 2016 Sep 13.
- 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. This study is not recruiting at the moment.
Mahmoud S. Ragab, Bsc 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 Lung volume recruitment technique and Traditional chest physiotherapy in people with Mechanical Ventilation Complication and Diaphragm Issues, 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 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 22 Nov 2021. 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?
Cough peak flow rate (time frame: "Day 4"). The study lists 3 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 NCT05128552, 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 22 Nov 2021.