Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation on Postoperative Pulmonary Complications: a Randomized Trial

Conditions
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Thoracic Diseases

Intervention / Treatment
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* Device: Mechanical insufflator-exsufflator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical insufflator-exsufflator<br>Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day. | Device: Mechanical insufflator-exsufflator<br>* 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.<br>|
| No Intervention: Standard care<br>Standard postoperative care without mechanical insufflator-exsufflator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | On 24 hour after operation | 
| Sputum volume 24 hours after tracheal extubation | Sputum volume 24 hours after tracheal extubation | On 24 hour after operation | 
| Peak expiratory flow (PEF) 48 hours after surgery | Peak expiratory flow (PEF) 48 hours after surgery, | 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 | On 36-48 hour after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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). | Day 7 after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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One-lung ventilation, Postoperative pulmonary complications, Mechanical insufflator-exsufflator, Randomized trial