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

Last updated: April 29, 2025
Sponsor: I.M. Sechenov First Moscow State Medical University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Mechanical insufflator-exsufflator

Clinical Study ID

NCT06180148
COUGH-001
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Video-assisted thoracoscopic surgery using one-lung ventilation

  • Age 18-65 years Forced expiratory volume in one second (FEV1) 60% of predicted ormore

  • Absence of pronounced bronchial secretion before surgery

  • Written informed consent.

Exclusion

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 duringpreoperative 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 5points

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: Mechanical insufflator-exsufflator
Phase:
Study Start date:
January 09, 2024
Estimated Completion Date:
November 30, 2024

Study 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.

Connect with a study center

  • Sechenov University Clinic#4

    Moscow,
    Russian Federation

    Site Not Available

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