Clinical trial NCT06180148: Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation
Official title: Use of Mechanical Insufflator-exsufflator in Patients After Video-assisted Thoracoscopic Operations With One-lung Ventilation on Postoperative Pulmonary Complications: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Diseases
Keywords: One-lung ventilation
Postoperative pulmonary complications
Mechanical insufflator-exsufflator
Randomized trial
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 6 hours after tracheal extubation
timeFrame: On 6 hour after operation
measure: Peripheral oxygen saturation level (SpO2) when breathing atmospheric air 24 hours after tracheal extubation
timeFrame: On 24 hour after operation
measure: Sputum volume 24 hours after tracheal extubation
timeFrame: On 24 hour after operation
measure: Peak expiratory flow (PEF) 48 hours after surgery
timeFrame: On 48 hour after operation
measure: The volume of atelectasis on chest computed tomography 36-48 hours after tracheal extubation
timeFrame: On 36-48 hour after operation
Secondary outcomes:
measure: Pain according to visual analogue scale (VAS) of pain 6 hours after tracheal extubation
timeFrame: On 6 hour after operation
measure: Pain according to visual analogue scale (VAS) of pain 24 hours after tracheal extubation
timeFrame: On 24 hour after operation
measure: Dyspnea according to visual analogue scale (VAS) of dyspnea 6 hours after tracheal extubation
timeFrame: On 6 hour after operation
measure: Dyspnea according to visual analogue scale (VAS) of dyspnea 24 hours after tracheal extubation
timeFrame: On 24 hour after operation
measure: Postoperative pulmonary complications
timeFrame: Day 7 after operation
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University Clinic#4
Study officials:
References: