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

April 29, 2025 updated by: I.M. Sechenov First Moscow State Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Mechanical insufflator-exsufflator
Standard postoperative care plus mechanical insufflator-exsufflator during the first postoperative day.
Device: 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.
No Intervention: Standard care
Standard postoperative care without mechanical insufflator-exsufflator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
On 6 hour after operation
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
On 24 hour after operation
Sputum volume 24 hours after tracheal extubation
Time Frame: On 24 hour after operation
Sputum volume 24 hours after tracheal extubation
On 24 hour after operation
Peak expiratory flow (PEF) 48 hours after surgery
Time Frame: On 48 hour after operation
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
Time Frame: On 36-48 hour after operation
The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
On 36-48 hour after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
On 6 hour after operation
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)
On 24 hour after operation
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)
On 6 hour after operation
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)
On 24 hour after operation
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).
Day 7 after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
I.M. Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COUGH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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