[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590637":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":41,"centralContacts":46,"locations":31,"responsibleParty":54,"collaborators":31,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":31,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":31,"enrollmentInfo":65,"targetDuration":31,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":80,"whyStopped":31,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":31},{"fullName":5,"class":6},"Medical University of Silesia","OTHER",[8,14,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"No respiratory stabilization before FOB: HFNC","ACTIVE_COMPARATOR","The use of HFNC in pateints with chronic respiratory acidosis undergoing diagnostic FOB without stabilizing their respiratory paramethers before the procedure (pH 7.35-7.45; pCO2 \\>45 mmHg; HCO3- \\> 27 mmol\u002Fl) HFNC settings: flow 60L\u002Fmin, temperature 34 ºC and FiO2 under saturation control to achieve SpO2≥ 92%,",[13],"Device: Use of HFNC during FOB as a respiratory support method",{"label":15,"type":10,"description":16,"interventionNames":17},"No respiratory stabilization before FOB: NIV","The use of NIV in pateints with chronic respiratory acidosis undergoing diagnostic FOB without stabilizing their respiratory paramethers before the procedure (pH 7.35-7.45; pCO2 \\>45 mmHg; HCO3- \\> 27 mmol\u002Fl) NIV settings: ST mode (spontaneous to forced), number of breaths 16-18\u002Fminute, EPAP (expiratory positive pressure) 6-12 cmH2O, Tins (duration) 0.8-1.1s, PS 12-23 cm H2O and oxygen flow under saturation control to achieve SpO2≥ 92%",[18],"Device: Use of NIV during FOB as a respiratory support method",{"label":20,"type":10,"description":21,"interventionNames":22},"Respiratory stabilization before FOB: HFNC","Use of HFNC during FOB as a respiratory support method The use of HFNC in pateints with chronic respiratory acidosis undergoing diagnostic FOB with stabilization of their respiratory paramethers before the procedure (pH 7.35-7.45; pCO2 35-45 mmHg; HCO3- \\>27 mmol\u002Fl) HFNC settings: flow 60L\u002Fmin, temperature 34 ºC and FiO2 under saturation control to achieve SpO2≥ 92%,",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Respiratory stabilization before FOB: NIV","The use of NIV in pateints with chronic respiratory acidosis undergoing diagnostic FOB with stabilization of their respiratory paramethers before the procedure (pH 7.35-7.45; pCO2 35-45 mmHg; HCO3- \\>27 mmol\u002Fl) NIV settings: ST mode (spontaneous to forced), number of breaths 16-18\u002Fminute, EPAP (expiratory positive pressure) 6-12 cmH2O, Tins (duration) 0.8-1.1s, PS 12-23 cm H2O and oxygen flow under saturation control to achieve SpO2≥ 92%",[18],{"label":28,"type":29,"description":30,"interventionNames":31},"Respiratory stabilization before FOB: passive oxygen","NO_INTERVENTION","The use of passive oxygen in pateints with chronic respiratory acidosis undergoing diagnostic FOB with stabilization of their respiratory paramethers before the procedure (pH 7.35-7.45; pCO2 35-45 mmHg; HCO3- \\>27 mmol\u002Fl)",null,[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":31},"DEVICE","Use of NIV during FOB as a respiratory support method","The aim of this project is to assess the safety, indications and contrindications to perform bronchofiberoscopy for diagnostic purposes in patient with chronic respiratory acidosis with the use of Non-invasive Ventilation (NIV) and High Flow Nasal Cannula (HNFC). In addition we want to determine the extent to which the usage of respiratory support during bronchofiberoscopy (BF) will help to avoid complications such as hypoxemia, decompensation of chronic respiratory failure, deterioration of gas exchange and hemodynamic instability, as well as intubation.",[15,24],{"type":34,"name":39,"description":36,"armGroupLabels":40,"otherNames":31},"Use of HFNC during FOB as a respiratory support method",[9,20],[42],{"name":43,"affiliation":44,"role":45},"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",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},"Mikołaj Rycerski, Student","CONTACT","+48530379348","miko.ryc99@gmail.com",{"name":43,"role":49,"phone":31,"phoneExt":31,"email":53},"simon.mds@poczta.fm",{"type":55,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100590637","respiratory-stabilization-in-chronic-acidosis-before-bronchofiberoscopy--non-invasive-ventilation-effectivenes-100590637",false,"NCT06970002","Respiratory Stabilization in Chronic Acidosis Before Bronchofiberoscopy & Non-Invasive Ventilation Effectivenes","Assessment of the Importance of Respiratory Stabilization in Patients With Chronic Respiratory Acidosis Before a Diagnostic Bronchofiberoscopy, as Well as the Effectiveness of Different Types of Non-invasive Ventilation During the Procedure","Inclusion Criteria:\n\n1. Patient ≥ 18 years of age with indications for diagnostic bronchoscopy:\n\n   ◦ Diagnostic test: suspected lung cancer, suspected sarcoidosis, mediastinal lymphadenopathy,\n2. Patient who signed a written informed consent to participate in the study,\n3. pCO2 \\> 45 mmHg and\u002For HCO3- \\> 27 mmol\u002Fl but pH ≥ 7.35 in a blood gas test performed immediately before qualification for bronchoscopy.\n\nExclusion Criteria:\n\n1. Lack of written informed consent of the subject to participate in the research project,\n2. Coronary artery disease CCS III\u002FIV,\n3. Hemodynamic failure, use of pressor amines, myocardial infarction in the last 2 weeks without PCI treatment, unstable angina pectoris, severe arrhythmias - especially ventricular,\n4. Pneumothorax not secured with drainage,\n5. Platelet count \\\u003C20,000\u002Fµl, if platelets are not transfused immediately before\u002Fduring the procedure,\n6. INR \\> 1.5xULN or APTT \\>36 s.1.5xULN, in the case of diagnostic FOB \\[16\\],\n7. Anemia: hemoglobin (Hb) level \\\u003C6 g\u002Fdl or 6-10 g\u002Fdl if the physician prescribes a blood transfu-sion,\n8. Patients who were intubated before randomization.","ALL","18 Years",{"count":66,"type":67},210,"ESTIMATED","INTERVENTIONAL",[70],"NA","Bronchofiberoscopy (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, two- armed randomized controlled trial (RCT).\n\nThe investigators aim to study two patients groups, based on FOB indications and the type of respiratory acidosis:\n\n1\\) Diagnostic FOB; patients with chronic respiratory acidosis (pH ≥7.35; pCO2 \\> 45mmHg and\u002For HCO3- \\>27 mmol\u002Fl);\n\n1. randomized to: passive oxygen, NIV, HFNC;\n2. total number of participants: 210\n\nRandomization:\n\ntwo-step randomization (1st randomization :a or b; 2nd randomization: i- iii method of respiratory support):\n\na. Stabilization of respiratory parameters before FOB (pH 7.35-7.45; pCO2 35-45 mmHg; HCO3- \\>27 mmol\u002Fl) i. NIV ii. HFNC iii. Passive oxygen therapy b. FOB right away (pH 7.35-7.45; pCO2 \\>45 mmHg; HCO3- \\> 27 mmol\u002Fl) i. NIV ii. HFNC\n\nBefore FOB, both groups 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 both studied groups.\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 respiratory acidosis, leading to a shorter time from admission to diagnosis, better tolerance during the procedure, quicker recovery after procedure.",[73],"Chronic Respiratory Acidosis",[75,76,77,78,79,73],"Bronchofiberoscopy (FOB)","High Flow Nasal Cannula (HNFC)","Non-Invasive Ventilation (NIV)","Passive Oxygen Therapy","Lung Disease Diagnosis","NOT_YET_RECRUITING","2025-05-05",{"date":83,"type":84},"2025-05-14","ACTUAL",{"date":86,"type":67},"2025-10-01",{"date":88,"type":67},"2028-10-31",{"name":5,"class":6}]