Thoracic DiseasesNCT06180148
Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation
A study testing Mechanical insufflator-exsufflator in people with Thoracic Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Diseases
- What is being tested?
- Mechanical insufflator-exsufflator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2024to 30 Nov 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Video-assisted thoracoscopic surgery using one-lung ventilation
- Age 18-65 years Forced expiratory volume in one second (FEV1) 60% of predicted or more
- Absence of pronounced bronchial secretion before surgery
- Written informed consent.
Who cannot join
- Age less than 18 and more than 65 years
- Presence of pneumothorax 6 hours after surgery on radiography
- Pulmonary hemorrhage of any intensity
- Unstable hemodynamics
- Forced expiratory volume in one second (FEV1) is less than 60% of predicted during preoperative examination
- The scope of the operation is more than a lobectomy
Show all 9Show fewer
- Bilateral and combined operations
- Mechanical ventilation after surgery for more than 6 hours
- Anesthesia risk according to American Society of Anesthesiologists (ASA) 4 and 5 points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation on Postoperative Pulmonary Complications: a Randomized Trial
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The study aimed to compare the effectiveness of using a mechanical insufflator-exsufflator after video-assisted thoracoscopic surgery using one-lung ventilation to reduce postoperative pulmonary complications as compared to standard therapy.
Read the detailed description
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The incidence of PPC ranges from 5% to 80%. Patients undergoing thoracic surgery are usually at high risk. Most often these are elderly people with concomitant diseases. Most of these patients are smokers, have occupational exposures, and are therefore at even greater risk of developing pulmonary complications. Part of their problem is due to poor baseline pulmonary function. Improving mucus production in the postoperative period using a mechanical insufflator-exsufflator may help reduce the incidence of complications.
- Conditions
- Thoracic Diseases
- Being tested
- Mechanical insufflator-exsufflator
- Keywords
- One-lung ventilation, Postoperative pulmonary complications, Mechanical insufflator-exsufflator, Randomized trial
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical insufflator-exsufflatorDevice
In the active comparator group a mechanical insufflator-exsufflator will be used in the postoperative period 6 and 24 hours after extubation as follows ("coughing maneuver"): application of inspiratory pressure of 40-70 cm of water (the minimum value to achieve a peak cough flow of 300 l/min) for 2 seconds with the subsequent creation of an expiratory vacuum of -40 cm of water within 2 seconds. During inhalation and exhalation, the patient will apply oscillations with a frequency of 10 Hz and an amplitude of 10 cm of water. A series of 10 such maneuvers will be used, with a pause of a few seconds to ensure patient comfort. The "coughing" maneuver will be performed through an oronasal mask tightly pressed to the face.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical insufflator-exsufflator | Active comparator | Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day. Receives: Device: Mechanical insufflator-exsufflator |
| Standard care | No intervention | Standard postoperative care without mechanical insufflator-exsufflator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
Measured: On 6 hour after operation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
Measured: On 24 hour after operation
Sputum volume 24 hours after tracheal extubation
Sputum volume 24 hours after tracheal extubation
Measured: On 24 hour after operation
Peak expiratory flow (PEF) 48 hours after surgery
Peak expiratory flow (PEF) 48 hours after surgery,
Measured: On 48 hour after operation
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
Measured: On 36-48 hour after operation
Secondary outcomes (5)
Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation
Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation (from 1 to 10 points, where 1 point - minimal pain level, 10 points - maximal pain level)
Measured: On 6 hour after operation
Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation
Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation (from 1 to 10 points, where 1 point - minimal pain level, 10 points - maximal pain level)
Measured: On 24 hour after operation
Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation
Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation (from 1 to 10 points, where 1 point - minimal comfort, 10 points - maximal comfort)
Measured: On 6 hour after operation
Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation
Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation (from 1 to 10 points, where 1 point - minimal comfort, 10 points - maximal comfort)
Measured: On 24 hour after operation
Postoperative pulmonary complications
Development of postoperative pulmonary complications - atelectasis (focus of consolidation on CT scan of the lungs without signs of infection), respiratory tract infection - tracheobronchitis or pneumonia (CPIS score>5 points), hypoxemia (SpO2<90% when breathing atmospheric air), pleural effusion (more than 300 ml), pneumothorax, bronchospasm (clinically - the presence of dry wheezing).
Measured: Day 7 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start9 Jan 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180148
- Sponsor's protocol ID
- COUGH-001
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation on Postoperative Pulmonary Complications: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06180148
- Acronym / sponsor ID
- COUGH-001
- Conditions
- Thoracic Diseases
- Keywords
- One-lung ventilation, Postoperative pulmonary complications, Mechanical insufflator-exsufflator, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 22 Dec 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.
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The study aimed to compare the effectiveness of using a mechanical insufflator-exsufflator after video-assisted thoracoscopic surgery using one-lung ventilation to reduce postoperative pulmonary complications as compared to standard therapy.
Detailed description
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The incidence of PPC ranges from 5% to 80%. Patients undergoing thoracic surgery are usually at high risk. Most often these are elderly people with concomitant diseases. Most of these patients are smokers, have occupational exposures, and are therefore at even greater risk of developing pulmonary complications. Part of their problem is due to poor baseline pulmonary function. Improving mucus production in the postoperative period using a mechanical insufflator-exsufflator may help reduce the incidence of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical insufflator-exsufflator | Active comparator | Device: Mechanical insufflator-exsufflatorStandard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day. |
| Standard care | No intervention | –Standard postoperative care without mechanical insufflator-exsufflator. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Video-assisted thoracoscopic surgery using one-lung ventilation
- Age 18-65 years Forced expiratory volume in one second (FEV1) 60% of predicted or more
- Absence of pronounced bronchial secretion before surgery
- Written informed consent.
Key exclusion criteria (9 listed)
- Age less than 18 and more than 65 years
- Presence of pneumothorax 6 hours after surgery on radiography
- Pulmonary hemorrhage of any intensity
- Unstable hemodynamics
- Forced expiratory volume in one second (FEV1) is less than 60% of predicted during preoperative examination
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 |
|---|---|---|
| Mechanical insufflator-exsufflatorIn the active comparator group a mechanical insufflator-exsufflator will be used in the postoperative period 6 and 24 hours after extubation as follows ("coughing maneuver"): application of inspiratory pressure of 40-70 cm of water (the minimum value to achieve a peak cough flow of 300 l/min) for 2 seconds with the subsequent creation of an expiratory vacuum of -40 cm of water within 2 seconds. During inhalation and exhalation, the patient will apply oscillations with a frequency of 10 Hz and an amplitude of 10 cm of water. A series of 10 such maneuvers will be used, with a pause of a few seconds to ensure patient comfort. The "coughing" maneuver will be performed through an oronasal mask tightly pressed to the face. | Device | Mechanical insufflator-exsufflator |
Primary outcome
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
Time frame: On 6 hour after operation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
Time frame: On 24 hour after operation
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
Sputum volume 24 hours after tracheal extubation
Time frame: On 24 hour after operation
Sputum volume 24 hours after tracheal extubation
Peak expiratory flow (PEF) 48 hours after surgery
Time frame: On 48 hour after operation
Peak expiratory flow (PEF) 48 hours after surgery,
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
Time frame: On 36-48 hour after operation
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
5 secondary outcomes
Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation
Time frame: On 6 hour after operation
Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation
Time frame: On 24 hour after operation
Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation
Time frame: On 6 hour after operation
Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation
Time frame: On 24 hour after operation
Postoperative pulmonary complications
Time frame: Day 7 after operation
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 2 May 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. 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 Mechanical insufflator-exsufflator in people with Thoracic Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 9 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 2 May 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 Russia. 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?
Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation (time frame: On 6 hour after operation). The study lists 5 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 2 May 2025.