An interventional study of Mechanical insufflator-exsufflator in Thoracic Diseases, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
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.
68 studies on the registry are indexed under Thoracic Diseases; 14 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 50 interventional studies indexed under Thoracic Diseases.
Browse Thoracic Diseases studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day.
Device: Mechanical insufflator-exsufflator
Standard postoperative care without mechanical insufflator-exsufflator.
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.
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
Time frame: 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
Time frame: On 24 hour after operation
Sputum volume 24 hours after tracheal extubation
Sputum volume 24 hours after tracheal extubation
Time frame: On 24 hour after operation
Peak expiratory flow (PEF) 48 hours after surgery
Peak expiratory flow (PEF) 48 hours after surgery,
Time frame: 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
Time frame: On 36-48 hour after operation
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Day 7 after operation
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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I.M. Sechenov First Moscow State Medical University