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

Not Applicable

Completed

• Conditions: Thoracic Diseases
• Interventions: Device: Mechanical insufflator-exsufflator

• Registration Number: NCT06180148
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-22
• Study Start: 2024-01-09
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical insufflator-exsufflator	Mechanical insufflator-exsufflator	Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day.

Primary Outcome Measures

Name	Time	Method
Sputum volume 24 hours after tracheal extubation	On 24 hour after operation	Sputum volume 24 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
Peak expiratory flow (PEF) 48 hours after surgery	On 48 hour after operation	Peak expiratory flow (PEF) 48 hours after surgery,
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
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

Secondary Outcome Measures

Name	Time	Method
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).
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)
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)
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)

Trial Locations

Locations (1)

Sechenov University Clinic#4; 🇷🇺 Moscow, Russian Federation