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

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Thoracic Diseases

Treatments: Device: Mechanical insufflator-exsufflator

Study type: Interventional

Funder types: Other

Identifiers

NCT06180148

COUGH-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Mechanical insufflator-exsufflator

Active Comparator group

Description:

Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day.

Treatment:

Device: Mechanical insufflator-exsufflator

Standard care

No Intervention group

Description:

Standard postoperative care without mechanical insufflator-exsufflator.