Thoracic SurgeryNCT03639974
Positive Expiratory Pressure With Blow-bottle Device Versus EPAP After Postoperative Cardiac Surgery
A study testing PEP in a blow-bottle device, EPAP and conventional physiotherapy in people with Thoracic Surgery, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- PEP in a blow-bottle device, EPAP and conventional physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 23 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiovascular surgery of:
- coronary artery bypass graft surgery alone
- coronary artery bypass graft surgery combined with aortic valve surgery
- coronary artery bypass graft surgery combined with bicuspid valve surgery
- coronary artery bypass graft surgery combined with tricuspid valve surgery
- Aortic valve surgery
Show all 9Show fewer
- Bicuspid valve surgery
- Tricuspid valve surgery
- All on spontaneous ventilation or with supplemental oxygen support.
Who cannot join
- Patients with hemodynamic instability (heart rate> 120bpm, clinically important hypotension - vasopressor dose ≥ 0.1mcg / kg / min)
- Cardiac arrhythmia
- Heart transplantation
- Angina at rest and/or minor efforts
- Mechanical ventilation for more than 24 hours
- Re-hospitalized patients with decompensated heart failure
Show all 32Show fewer
- Noninvasive mechanical ventilation
- Non-collaborative and with cognitive inability to understand the procedures
- Reintubated patients
- Re-operated patients
- In order to perform the pulmonary function test, patients may not present the following contraindications:
- hemoptysis
- recent angina
- retinal detachment
- hypertensive crisis
- pulmonary edema
- thoracic aortic aneurysm
- In order to perform the respiratory muscle strength test, patients may not present the following contraindications:
- acute myocardial infarction
- recent unstable angina
- severe and uncontrolled systemic arterial hypertension
- aortic aneurysm
- pneumothorax
- pleurocutaneous or pulmonary fistulas
- surgery or recent trauma to the upper airways, chest or abdomen
- abdominal hernia
- acute middle ear problems
- glaucoma or retinal detachment
- hydrocephalus
- meningocele
- neurological processes that favor the choking of tonsils
- general state of physical or mental impairment that impedes the patient's collaboration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expiratory Positive Pressure With Blow-bottle Device Versus Expiratory Positive Airway Pressure (EPAP) in Patients After Postoperative Cardiac Surgery: Randomized Clinical Trial
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients through a randomized clinical trial. Methods: The study was approved by the Research Ethics Committee of the Hospital de Clínicas of Porto Alegre (CAEE: 70213617.6.0000.5327). Patients undergoing cardiac surgery were randomized into three groups: positive expiratory pressure with blow-bottle device associated with conventional physiotherapy (G1), positive expiratory pressure in the airways with unidirectional valve associated with conventional physiotherapy (G2), and the third group only the conventional physiotherapy of HCPA cardiac intensive care unit (G3). Initially, an evaluation was performed through spirometry, manovacuometry, radiological changes in the preoperative period, prior to the interventions (immediate postoperative) and on the third postoperative day, immediately prior to cardiac intensive care unit discharge. Pulmonary complications were assessed on the third postoperative day, and length of stay (at the Intensive Care Unit and hospital) were recorded untill discharge.
Read the detailed description
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients. Methods:This is a randomized clinical trial, with patients in postoperative cardiac surgery. On the first day of postoperative, the patients will be randomized into three groups: 1 group that will receive positive expiratory pressure with blow-bottle device associated with conventional physiotherapy; 2- group that will receive positive expiratory pressure in the airways with valve unidirectional therapy associated with conventional physiotherapy; 3- group that will only receive conventional physiotherapy. The intervention of the positive expiratory pressure with blow-bottle device group will consist of exercise with a blow-bottle device of 10 cm high; the positive expiratory pressure in the airways group, exercise with unidirectional positive expiratory pressure valve (10cmH2O). Both the groups will perform three sets of 10 repetitions per day, by the third day of PO. The third group will receive conventional physiotherapy of intensive care unit. The outcomes evaluated will be: pulmonary function (primary), respiratory muscle strength, pulmonary complications, radiological changes and length of stay (at the Intensive CareUnit - ICU - and hospital). Assessment of pulmonary function, muscle strength and radiological changes will be performed in the preoperative period, prior to the interventions and on the third postoperative day, immediately prior to discharge of cardiac intensive care unit. Pulmonary complications and ICU length of stay will be recorded after discharge from intensive care unit cardiac. The length of hospital stay was recorded after hospital discharge.
- Conditions
- Thoracic Surgery
- Being tested
- PEP in a blow-bottle device, EPAP, conventional physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP in a blow-bottle deviceOther
A 500-milliliter enteral nutrition vial will be used, which will contain a hole in the side, where two silicone tubes of 20 centimeters long will be inserted together with tape on the bottleneck of the vial. To perform the exercise, the vial will be filled with water leaving a water column of 10 cm high. Deep inspirations will be requested at a volume greater than the tidal volume and less than the total lung capacity that can be performed via nasal or oral, then with the mouth connected to the extensors, the patient will exhale slowly, avoiding to totally empty the lungs. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA.
EPAPOther
The Vital Signs ® EPAP kit will be used. Exercises will be performed in the bed, and as soon as the patient is released by the medical team to leave the bed, they can be performed in the sitting position or in orthostasis. For performing the exercise, the EPAP mask will be connected to the face of the patient. The expiratory pressure will be adjusted to 10cmH2O. Deep inspirations will be requested at a volume greater than the tidal volume and below the total lung capacity, then the patient will exhale slowly. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA, as described in the conventional physiotherapy group.
conventional physiotherapyOther
Conventional physical therapy consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resisted lower limb exercises; stretching, cough and walking guidelines. Initially the exercises will be performed in the bed, as soon as this is withdrawn and the patient is released by the medical team to leave the bed, the progression of the exercises to be performed in the sitting position, orthostasis, and ambulation is performed, this usually occurs on the 2nd postoperative day, after the removal of the mediastinal drain . Under supervision of the physiotherapist, the protocol will be performed twice daily, two sets of ten repetitions.
| Study group | Role | What they receive |
|---|---|---|
| PEP in a blow-bottle device | Active comparator | Blow-bottle device of 10cmH2O. Receives: Other: PEP in a blow-bottle device |
| EPAP Positive airway expiratory pressure | Active comparator | EPAP with pressure of 10 cmH2O. Receives: Other: EPAP |
| conventional physiotherapy | Sham comparator | Ventilatory exercises, bronchial hygiene techniques, exercises for upper and lower limbs (previous motor condition) stretching, orientation and walking. Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function - forced vital capacity
Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.
Measured: three days
Pulmonary function - forced expiratory volume in the first second
Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration .
Measured: three days
Pulmonary function - the ratio: forced expiratory volume in the first second / forced vital capacity
Pulmonary function through spirometry, obtained through forced maneuver (forced vital capacity) and forced expiratory volume in the first second - represents the maximum expired volume at the first second of an maximum expiration.
Measured: three days
Secondary outcomes (15)
Respiratory muscle strength - maximum expiratory pressure
Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximum expiratory pressure.
Measured: three days
Respiratory muscle strength - maximal inspiratory pressure
Performed through a manometer in step cmH2O, of the brand Globalmed model MV300. Maximal inspiratory pressure will be measured.
Measured: three days
Pulmonary complications - atelectasis
According to the definitions of the European Journal of Anaesthesiology
Measured: three days
Pulmonary complications - pleural effusion
According to the definitions of the European Journal of Anaesthesiology
Measured: three days
Pulmonary complications - pneumothorax
According to the definitions of the European Journal of Anaesthesiology
Measured: three days
Pulmonary complications - pneumonia
According to the definitions of the European Journal of Anaesthesiology
Measured: three days
Pulmonary complications - respiratory infection
According to the definitions of the European Journal of Anaesthesiology
Measured: three days
Pulmonary complications - respiratory failure
According to the definitions of the European Journal of Anaesthesiology
Measured: three days
Radiological changes - pleural effusion
rated on chest X-ray, according to the scale proposed by Staton et al.
Measured: three days
Radiological changes - atelectasis
rated on chest X-ray, according to the scale proposed by Staton et al.
Measured: three days
Radiological changes - consolidation
rated on chest X-ray, according to the scale proposed by Staton et al.
Measured: three days
Radiological changes - pneumothorax
rated on chest X-ray, according to the scale proposed by Staton et al.
Measured: three days
Radiological changes - pulmonary edema
rated on chest X-ray, according to the scale proposed by Staton et al.
Measured: three days
Length of Intensive Care Unit (ICU) stay
Length of ICU stay (days) search electronic records
Measured: three days
Length of hospital stay
Length of hospital stay (days) search electronic records
Measured: up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Aug 2018
- Primary completion20 May 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- This is a randomized clinical trial that will be performed according to the CONSORT Statement (Consolidated Standards of ReportingTrials).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Graciele Sbruzzi, doctor, Principal investigator, HCPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639974
- Sponsor's protocol ID
- 17-0460
- Status last verified
- Dec 2019
- First submitted
- 13 Jul 2018
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pieczkoski SM, de Oliveira AL, Haeffner MP, Azambuja ACM, Sbruzzi G. Positive expiratory pressure in postoperative cardiac patients in intensive care: A randomized controlled trial. Clin Rehabil. 2021 May;35(5):681-691. doi: 10.1177/0269215520972701. Epub 2020 Nov 24.
PubMed 33233946
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Positive Pressure With Blow-bottle Device Versus Expiratory Positive Airway Pressure (EPAP) in Patients After Postoperative Cardiac Surgery: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03639974
- Acronym / sponsor ID
- 17-0460
- Conditions
- Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 21 Aug 2018 (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.
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients through a randomized clinical trial. Methods: The study was approved by the Research Ethics Committee of the Hospital de Clínicas of Porto Alegre (CAEE: 70213617.6.0000.5327). Patients undergoing cardiac surgery were randomized into three groups: positive expiratory pressure with blow-bottle device associated with conventional physiotherapy (G1), positive expiratory pressure in the airways with unidirectional valve associated with conventional physiotherapy (G2), and the third group only the conventional physiotherapy of HCPA cardiac intensive care unit (G3). Initially, an evaluation was performed through spirometry, manovacuometry, radiological changes in the preoperative period, prior to the interventions (immediate postoperative) and on the third postoperative day, immediately prior to cardiac intensive care unit discharge. Pulmonary complications were assessed on the third postoperative day, and length of stay (at the Intensive Care Unit and hospital) were recorded untill discharge.
Detailed description
Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients. Methods:This is a randomized clinical trial, with patients in postoperative cardiac surgery. On the first day of postoperative, the patients will be randomized into three groups: 1 group that will receive positive expiratory pressure with blow-bottle device associated with conventional physiotherapy; 2- group that will receive positive expiratory pressure in the airways with valve unidirectional therapy associated with conventional physiotherapy; 3- group that will only receive conventional physiotherapy. The intervention of the positive expiratory pressure with blow-bottle device group will consist of exercise with a blow-bottle device of 10 cm high; the positive expiratory pressure in the airways group, exercise with unidirectional positive expiratory pressure valve (10cmH2O). Both the groups will perform three sets of 10 repetitions per day, by the third day of PO. The third group will receive conventional physiotherapy of intensive care unit. The outcomes evaluated will be: pulmonary function (primary), respiratory muscle strength, pulmonary complications, radiological changes and length of stay (at the Intensive CareUnit - ICU - and hospital). Assessment of pulmonary function, muscle strength and radiological changes will be performed in the preoperative period, prior to the interventions and on the third postoperative day, immediately prior to discharge of cardiac intensive care unit. Pulmonary complications and ICU length of stay will be recorded after discharge from intensive care unit cardiac. The length of hospital stay was recorded after hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized clinical trial that will be performed according to the CONSORT Statement (Consolidated Standards of ReportingTrials).
| Arm | Type | Receives |
|---|---|---|
| PEP in a blow-bottle device | Active comparator | Other: PEP in a blow-bottle deviceBlow-bottle device of 10cmH2O. |
| EPAP Positive airway expiratory pressure | Active comparator | Other: EPAPEPAP with pressure of 10 cmH2O. |
| conventional physiotherapy | Sham comparator | Other: conventional physiotherapyVentilatory exercises, bronchial hygiene techniques, exercises for upper and lower limbs (previous motor condition) stretching, orientation and walking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- coronary artery bypass graft surgery alone
- coronary artery bypass graft surgery combined with aortic valve surgery
- coronary artery bypass graft surgery combined with bicuspid valve surgery
- coronary artery bypass graft surgery combined with tricuspid valve surgery
- Aortic valve surgery
Key exclusion criteria (32 listed)
- Patients with hemodynamic instability (heart rate> 120bpm, clinically important hypotension - vasopressor dose ≥ 0.1mcg / kg / min)
- Cardiac arrhythmia
- Heart transplantation
- Angina at rest and/or minor efforts
- Mechanical ventilation for more than 24 hours
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 |
|---|---|---|
| PEP in a blow-bottle deviceA 500-milliliter enteral nutrition vial will be used, which will contain a hole in the side, where two silicone tubes of 20 centimeters long will be inserted together with tape on the bottleneck of the vial. To perform the exercise, the vial will be filled with water leaving a water column of 10 cm high. Deep inspirations will be requested at a volume greater than the tidal volume and less than the total lung capacity that can be performed via nasal or oral, then with the mouth connected to the extensors, the patient will exhale slowly, avoiding to totally empty the lungs. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA. | Other | PEP in a blow-bottle device |
| EPAPThe Vital Signs ® EPAP kit will be used. Exercises will be performed in the bed, and as soon as the patient is released by the medical team to leave the bed, they can be performed in the sitting position or in orthostasis. For performing the exercise, the EPAP mask will be connected to the face of the patient. The expiratory pressure will be adjusted to 10cmH2O. Deep inspirations will be requested at a volume greater than the tidal volume and below the total lung capacity, then the patient will exhale slowly. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA, as described in the conventional physiotherapy group. | Other | EPAP Positive airway expiratory pressure |
| conventional physiotherapyConventional physical therapy consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resisted lower limb exercises; stretching, cough and walking guidelines. Initially the exercises will be performed in the bed, as soon as this is withdrawn and the patient is released by the medical team to leave the bed, the progression of the exercises to be performed in the sitting position, orthostasis, and ambulation is performed, this usually occurs on the 2nd postoperative day, after the removal of the mediastinal drain . Under supervision of the physiotherapist, the protocol will be performed twice daily, two sets of ten repetitions. | Other | conventional physiotherapy |
Primary outcome
Pulmonary function - forced vital capacity
Time frame: three days
Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.
Pulmonary function - forced expiratory volume in the first second
Time frame: three days
Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration .
Pulmonary function - the ratio: forced expiratory volume in the first second / forced vital capacity
Time frame: three days
Pulmonary function through spirometry, obtained through forced maneuver (forced vital capacity) and forced expiratory volume in the first second - represents the maximum expired volume at the first second of an maximum expiration.
15 secondary outcomes
Respiratory muscle strength - maximum expiratory pressure
Time frame: three days
Respiratory muscle strength - maximal inspiratory pressure
Time frame: three days
Pulmonary complications - atelectasis
Time frame: three days
Pulmonary complications - pleural effusion
Time frame: three days
Pulmonary complications - pneumothorax
Time frame: three days
Pulmonary complications - pneumonia
Time frame: three days
Pulmonary complications - respiratory infection
Time frame: three days
Pulmonary complications - respiratory failure
Time frame: three days
Radiological changes - pleural effusion
Time frame: three days
Radiological changes - atelectasis
Time frame: three days
Radiological changes - consolidation
Time frame: three days
Radiological changes - pneumothorax
Time frame: three days
Radiological changes - pulmonary edema
Time frame: three days
Length of Intensive Care Unit (ICU) stay
Time frame: three days
Length of hospital stay
Time frame: up to 25 days
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 10 Dec 2019.
- Derived from this study: PubMed 33233946Pieczkoski SM, de Oliveira AL, Haeffner MP, Azambuja ACM, Sbruzzi G. Positive expiratory pressure in postoperative cardiac patients in intensive care: A randomized controlled trial. Clin Rehabil. 2021 May;35(5):681-691. doi: 10.1177/0269215520972701. Epub 2020 Nov 24.
- 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.
Graciele Sbruzzi, doctor principal investigator
HCPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP in a blow-bottle device, EPAP and conventional physiotherapy in people with Thoracic Surgery, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 9 inclusion and 32 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 10 Dec 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Pulmonary function - forced vital capacity (time frame: three days). 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 NCT03639974, which also lists 1 linked publication.
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 10 Dec 2019.