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

Thoracic Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180148
• Other study ID #: COUGH-001
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Andrey I Yaroshetskiy, MD, PhD, ScD
• Phone: +79859900148
• Email: dr.intensivist[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Russian Federation	Sechenov University Clinic#4	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Sputum volume 24 hours after tracheal extubation	Sputum volume 24 hours after tracheal extubation	On 24 hour after operation
Primary	Peak expiratory flow (PEF) 48 hours after surgery	Peak expiratory flow (PEF) 48 hours after surgery,	On 48 hour after operation
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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