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

NCT06180148 | Completed DMC

• 1 other identifier: COUGH-001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Diseases

Keywords

One-lung ventilation; Postoperative pulmonary complications; Mechanical insufflator-exsufflator; Randomized trial

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Sputum volume 24 hours after tracheal extubation

  Sputum volume 24 hours after tracheal extubation

  On 24 hour after operation

• Peak expiratory flow (PEF) 48 hours after surgery

  Peak expiratory flow (PEF) 48 hours after surgery,

  On 48 hour after operation

• 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 Outcomes (5)

• 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 24 hours after tracheal extubation

  On 24 hour after operation

• 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 24 hours after tracheal extubation

  On 24 hour after operation

• Postoperative pulmonary complications

  Day 7 after operation

Study Arms (2)

Mechanical insufflator-exsufflator

ACTIVE COMPARATOR

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

Device: Mechanical insufflator-exsufflator

Standard care

NO INTERVENTION

Standard postoperative care without mechanical insufflator-exsufflator.

Interventions

Mechanical insufflator-exsufflator 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.

Mechanical insufflator-exsufflator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov University Clinic#4

Moscow, Russia

Location

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: January 9, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 2, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)