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NCT Number: NCT06180148

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

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.

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Key information

Conditions

Thoracic Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sechenov University Clinic#4

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation

    Time frame: On 6 hour after operation

    Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation

  2. Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation

    Time frame: On 24 hour after operation

    Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation

  3. Sputum volume 24 hours after tracheal extubation

    Time frame: On 24 hour after operation

    Sputum volume 24 hours after tracheal extubation

  4. Peak expiratory flow (PEF) 48 hours after surgery

    Time frame: On 48 hour after operation

    Peak expiratory flow (PEF) 48 hours after surgery,

  5. The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation

    Time frame: On 36-48 hour after operation

    The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation

Secondary outcomes

  1. Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation

    Time frame: On 6 hour after operation

    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)

  2. Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation

    Time frame: On 24 hour after operation

    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)

  3. Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation

    Time frame: On 6 hour after operation

    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)

  4. Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation

    Time frame: On 24 hour after operation

    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)

  5. Postoperative pulmonary complications

    Time frame: Day 7 after operation

    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).

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

Use of Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation on Postoperative Pulmonary Complications: a Randomized Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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