Thoracic Diseases
Conditions
Keywords
One-lung ventilation, Postoperative pulmonary complications, Mechanical insufflator-exsufflator, Randomized trial
Brief 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. 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.
Interventions
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.
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation | On 36-48 hour after operation | The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation |
| Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation | 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 | 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 | On 24 hour after operation | Sputum volume 24 hours after tracheal extubation |
| Peak expiratory flow (PEF) 48 hours after surgery | On 48 hour after operation | Peak expiratory flow (PEF) 48 hours after surgery, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation | On 6 hour after operation | 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) |
| Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation | On 24 hour after operation | 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) |
| Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation | On 6 hour after operation | 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) |
| Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation | On 24 hour after operation | 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) |
| Postoperative pulmonary complications | Day 7 after operation | 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). |
Countries
Russia
Outcome results
None listed