protocolSection identificationModule nctId: NCT06320483, orgStudyIdInfo id: BT-01-23, briefTitle: Evaluation of the Effectiveness and Safety of Vibro-acoustic Pulmonary Therapy (VAPT) in Complex Therapy for Acute Respiratory Failure of Mixed Type I-II Stages in Comparison With Percussion Massage in Cardiac Surgical Patients in the Early Postoperative Period, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bark Technology LLP, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to evaluate the effectiveness and safety of vibro-acoustic pulmonary therapy (VAPT) in complex therapy for the acute respiratory failure of mixed type I-II stages in comparison with percussion massage in cardiac surgical patients in the early postoperative period., conditionsModule conditions: Cardiac Surgical Patients (CABG,Mammary Coronary Bypass Surgery,Plastic and Replacement of Valves, Atrial Septal Defect,Ventricular Septal Defect), designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 310, type: ESTIMATED, armsInterventionsModule interventions name: Vibroacoustic device BARK VibroLUNG, outcomesModule primaryOutcomes measure: Partial pressure of oxygen (PaO2), primaryOutcomes measure: Partial pressure of carbon dioxide (PaCO2), primaryOutcomes measure: Blood oxygen saturation level (SpO2) on pulse oximeter (peripheral capillary oxygenation), primaryOutcomes measure: Ratio of peripheral arterial oxygen saturation(SaO2) to the inspired fraction of oxygen FiO2, primaryOutcomes measure: Ratio of venous saturation (SvO2) to the inspired fraction of oxygen FiO2, primaryOutcomes measure: ROX Index, primaryOutcomes measure: P/F index (ratio of arterial blood PO2 to oxygen fraction), secondaryOutcomes measure: pH of blood, secondaryOutcomes measure: BE (base excess) of blood, secondaryOutcomes measure: CBC indicators (hemoglobin), secondaryOutcomes measure: CBC indicators (hematocrit), secondaryOutcomes measure: CBC indicators (platelets), secondaryOutcomes measure: Coagulogram indicators (prothrombin time), secondaryOutcomes measure: Coagulogram indicators (prothrombin index), secondaryOutcomes measure: Coagulogram indicators (international normalized ratio), secondaryOutcomes measure: Coagulogram indicators (fibrinogen), secondaryOutcomes measure: Coagulogram indicators (activated partial thromboplastin time), secondaryOutcomes measure: Number of days spent in the high dependency unit (intensive care ward in the department), secondaryOutcomes measure: Number of days in hospital, secondaryOutcomes measure: Number of days of O2 support, secondaryOutcomes measure: Proportion of patients with postoperative complications (pneumonia/atelectasis/pulmonary infiltration), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JSC "National Research Cardiac Surgery Center", status: RECRUITING, city: Astana, country: Kazakhstan, contacts name: Makhabbat Sansyzbaeva, role: CONTACT, phone: +7(7172)703158, email: cardiacsurgery@heartcenter.kz, contacts name: Timur Sayranovich, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.1801, lon: 71.44598, locations facility: State-owned public enterprise with the right of economic management "Atyrau Regional Cardiology Center", status: RECRUITING, city: Atyrau, country: Kazakhstan, contacts name: Marat Konysov, role: CONTACT, phone: +7(7122)50-69-26, email: cardiocenter@atyraumed.kz, contacts name: Zhangeldy Kadirov, role: SUB_INVESTIGATOR, geoPoint lat: 47.11667, lon: 51.88333, locations facility: State-owned public enterprise with the right of economic management "Regional Cardiology Center", status: RECRUITING, city: Oral, country: Kazakhstan, contacts name: Aktilek Umirbaev, role: CONTACT, phone: + 7701 338 35 04, email: kardio-zko@mail.ru, contacts name: Daniyar Arenov, role: SUB_INVESTIGATOR, geoPoint lat: 51.23333, lon: 51.36667, locations facility: State-owned public enterprise with the right of economic management "Pavlodar Regional Cardiology Center", status: RECRUITING, city: Pavlodar, country: Kazakhstan, contacts name: Gulzhanat Dzhakova, role: CONTACT, phone: +7(7182)39-08-00, email: info@cardiomedical.kz, contacts name: Inna Glowacka, role: SUB_INVESTIGATOR, geoPoint lat: 52.28333, lon: 76.96667, locations facility: State-owned public enterprise with the right of economic management "East Kazakhstan Regional Hospital", status: RECRUITING, city: Ust-Kamenogorsk, country: Kazakhstan, contacts name: Erlan Burkutov, role: CONTACT, phone: +7(7232)25-60-34, email: vko_obl@mail.ru, contacts name: Olesya Subbotina, role: SUB_INVESTIGATOR, geoPoint lat: 49.97143, lon: 82.60586, hasResults: False