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

NCT ID: NCT06180148

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2024-11-30

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.

Conditions

Thoracic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mechanical insufflator-exsufflator

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

Group Type: ACTIVE_COMPARATOR

Mechanical insufflator-exsufflator

Intervention Type: DEVICE

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.

Standard care

Standard postoperative care without mechanical insufflator-exsufflator.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sechenov University Clinic#4

Moscow, , Russia

Countries

Russia

Other Identifiers

COUGH-001

Identifier Type: -

Identifier Source: org_study_id