[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590640":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":48,"centralContacts":53,"locations":18,"responsibleParty":61,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":18,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":90,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":18},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14,19,23,28,32,36],{"label":9,"type":10,"description":11,"interventionNames":12},"pH \u003C 7,2, NIV","ACTIVE_COMPARATOR","The use of NIV in patients undergoing therapeutic FOB with the most severe type 2 respiratory failure",[13],"Device: Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure",{"label":15,"type":16,"description":17,"interventionNames":18},"pH \u003C 7,2, IMV (Intubation)","NO_INTERVENTION","The use of IMV in patients undergoing therapeutic FOB with the most severe type 2 respiratory failure (current gold standard at ICU fascilities)",null,{"label":20,"type":10,"description":21,"interventionNames":22},"7,3> pH ≥ 7,2, NIV","The use of NIV in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,3\\> pH ≥ 7,2.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"7,3> pH ≥ 7,2, HFNC","The use of HFNC in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,3\\> pH ≥ 7,2.",[27],"Device: Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure",{"label":29,"type":10,"description":30,"interventionNames":31},"7,35> pH ≥ 7,3, NIV","The use of NIV in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35\\> pH ≥ 7,3",[13],{"label":33,"type":10,"description":34,"interventionNames":35},"7,35> pH ≥ 7,3, HFNC","The use of HFNC in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35\\> pH ≥ 7,3",[27],{"label":37,"type":16,"description":38,"interventionNames":18},"7,35> pH ≥ 7,3, Passive Oxygen Therapy (control group)","The use of passive oxygen therapy (current gold standard) in patients with type 2 respiratory failure undergoing therapeutic FOB with a pH level: 7,35\\> pH ≥ 7,3",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":18},"DEVICE","Use of NIV during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure","The aim of the project is to assess the safety, indications and contraindications for therapeutic bronchofiberoscopy in patients with decompensated respiratory acidosis using: invasive mechanical ventilation (IMV), non-invasive mechanical ventilation (NIV) and high-flow nasal canulla (HFNC). Additionally, we want to determine to what extent the use of respiratory support during bronchofiberoscopy (BF) will avoid complications such as exacerbation of hypoxemia and\u002For acidosis and the occurrence of hemodynamic instability.",[29,20,9],{"type":41,"name":46,"description":43,"armGroupLabels":47,"otherNames":18},"Use of HFNC during therapeutic FOB as a respiratory support method in patients with type 2 respiratory failure",[33,24],[49],{"name":50,"affiliation":51,"role":52},"Szymon Skoczyński, PhD, professor of university","Department of Lung Diseases and Tuberculosis, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":18,"email":58},"Mikołaj Rycerski, Student","CONTACT","+48530379348","miko.ryc99@gmail.com",{"name":50,"role":56,"phone":18,"phoneExt":18,"email":60},"simon.mds@poczta.fm",{"type":62,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100590640","to-assess-the-types-of-mechanical-ventilation-in-enabling-therapeutic-bronchofiberoscopy-in-patients-with-decompensated-respiratory-acidosis-complete-respiratory-failure-100590640",false,"NCT06970041","To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure).","To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure)","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age with indications for bronchoscopy:\n\n   Therapeutic examination: pneumonia in people with impaired cough reflex, culture and toilet of the bronchial tree, respiratory tract hemorrhages treated with a bronchofiberoscope and aspiration of a foreign body, bronchial unblocking in advanced neoplastic disease.\n2. Patient who signed a written informed consent to participate in the study,\n3. pCO2 \\> 45 mmHg and pH \\\u003C 7.35 in a blood gas analysis performed directly during qualification for FOB.\n\nExclusion Criteria:\n\n1. Lack of written, informed consent of the subject to participate in the research project,\n2. Unstable coronary artery disease chronic coronary syndrome (CCS) III\u002FIV, circulatory failure New York Heart Association (NYHA) III\u002FIV (does not apply to tests for vital indications, e.g. aspiration of a foreign body),\n3. Hemodynamic insufficiency, constant use of pressor amines, myocardial infarction in the last 2 weeks without percutaneous coronary intervention (PCI) treatment, unstable angina pectoris, severe arrhythmias- especially ventricular,\n4. Chronic primary pulmonary hypertension, assessed during right heart catheterization WHO III\u002FIV,\n5. Pneumothorax not secured with drainage,\n6. Platelet count \\\u003C20,000\u002Fµl, if platelets are not transfused immediately before or during the procedure,\n7. International normalized ratio (INR)\\> 2 or activated partial thromboplastin time (APTT) \\> 36 s, in the case of therapeutic FOB \\[16\\],\n\nd. Anemia: hemoglobin (Hb) level \\\u003C6 g\u002Fdl or 6-10 g\u002Fdl if the physician prescribes a blood transfusion, h. Patients who were intubated before randomization.","ALL","18 Years",{"count":73,"type":74},315,"ESTIMATED","INTERVENTIONAL",[77],"NA","Background:\n\nBronchofiberoscopy (FOB) is a minimally invasive and safe procedure performed for diagnostic and therapeutic purposes. FOB frequently impairs respiratory function, which may lead to possible exacerbation of respiratory failure.\n\nCurrently, the most frequent respiratory support is passive oxygen therapy, but non-invasive ventilation (NIV) and high flow nasal cannula (HFNC) are increasingly attempted, however the optimal setting and indications for NIV and HFNC in patients undergoing FOB with respiratory acidosis, haven't been determined yet.\n\nMethods:\n\nThe study protocol describes a prospective, multicenter, three-armed randomized controlled trial (RCT).\n\nThe investigators aim to study patients undergoing a therapeutic bronchofiberoscopy with decompensated type 2 respiratory failure: (pH \\\u003C7.35 and pCO2 \\>45 mmHg);\n\n1. randomized to: passive oxygen, NIV, HFNC, invasive mechanical ventilation (IMV);\n2. total number of participants: 315. Before FOB, the patient group will undergo arterial blood gas analysis (ABG). During FOB there will be a continuous monitoring of vital signs as in: SpO2, FiO2, TcCO2, ECG, and Heart Rate. After FOB, the investigators are going to perform another ABG, mark endpoints, and complications, if any arise.\n\nResults:\n\nBased on the selected endpoints, or any complication related to FOB the investigators hope to determine which of the respiratory methods: passive oxygen, NIV, HFNC or IMV provides the best support, leading to a lower number of complications and overall a better tolerance of FOB by the patient. Additionally, our aim is to find the optimal settings for NIV and HFNC in the studied group.\n\nConclusions:\n\nThe results of this study are going to assess the need and the role of the optimal respiratory support method among patients with exacerbation of respiratory acidosis, leading to a shorter time from admission to full recovery, better tolerance during the procedure, quicker recovery after procedure.",[80,81],"Respiratory Failure With Hypercapnia","Therapeutic Bronchofiberoscopy",[83,84,85,86,87,88,89],"Bronchofiberoscopy (FOB)","High Flow Nasal Cannula (HNFC)","Non-Invasive Ventilation (NIV)","Passive Oxygen Therapy","Type 2 respiratory failure","Exacerbation of Chronic Respiratory Acidosis","Invasive Mechanical Ventilation (IMV)","NOT_YET_RECRUITING","2025-05-05",{"date":93,"type":94},"2025-05-14","ACTUAL",{"date":96,"type":74},"2025-10-01",{"date":98,"type":74},"2028-10-31",{"name":5,"class":6}]