[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":25,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":25,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":25,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Beijing Chao Yang Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"High-intensity NPPV","EXPERIMENTAL","Patients will receive high-intensity NPPV",[13,14],"Device: High-intensity NPPV","Device: Low-intensity NPPV",{"label":16,"type":17,"description":18,"interventionNames":19},"Low-intensity NPPV","ACTIVE_COMPARATOR","Patients will receive low-intensity NPPV",[13,14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","In the high-intensity NPPV group, IPAP is initially adjusted in increments\u002Fdecrements of 1-2 cmH2O, typically ranging from 20 to 30 cmH2O (or a tolerated maximum), to obtain a VT 10-15 mL\u002Fkg PBW and a respiratory rate \\\u003C25 breaths\u002Fmin. Subsequent adjustments to IPAP are based on the results of arterial blood gases (ABGs; up to 30 cmH2O) to achieve normocapnia (if possible), or to maximally decrease PaCO2 toward normocapnia if normocapnia can not be achieved. If PaCO2 decreases to less than 35 mmHg, IPAP will be decreased to achieve normocapnia.",[9,16],null,{"type":22,"name":16,"description":27,"armGroupLabels":28,"otherNames":25},"In the low-intensity NPPV group, as well as during the 6-hour trial of low-intensity NPPV, IPAP is initially adjusted in increments\u002Fdecrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT 6-10 mL\u002Fkg PBW and a respiratory rate \\\u003C25 breaths\u002Fmin. Subsequent adjustments to IPAP are based on the results of ABGs (up to 20 cmH2O) to achieve a pH of ≥7.35 and to reduce PaCO2 to a level deemed appropriate by the attending physician.",[9,16],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Ying ying Zheng, MD","CONTACT","86-10-18601022649","zyy19831016@163.com",[36],{"facility":5,"status":25,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":25},"Beijing","Beijing Municipality","100020","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},{"type":49,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100569267","impact-of-hi-nppv-vs-li-nppv-on-tolerance-among-aecopd-patients-100569267",false,"NCT06692023","Impact of HI-NPPV Vs LI-NPPV on Tolerance Among AECOPD Patients","Impact of High-Intensity-NIV Vs Low-intensity-NIV on Subjective Tolerance Amomg Patients with AECOPD : a Randomised Cross-over Pilot Study","Inclusion Criteria:\n\n* AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD);\n* Arterial pH \\\u003C7.35 and PaCO2 \\>45 mmHg at screening entry;\n* PaCO2 \\>45 mmHg after a 6-hour trial of low-intensity NPPV.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Excessive respiratory secretions with weak cough\n* Upper airway obstruction\n* Recent oral, facial, or cranial trauma or surgery\n* Recent gastric or esophageal surgery\n* Presence of restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, or severe abdominal distension)\n* Active upper gastrointestinal bleeding\n* Cardiac or respiratory arrest\n* Arterial oxygen tension\u002Ffraction of inspired oxygen (PaO2\u002FFiO2) \\\u003C100 mmHg\n* Pneumothorax\n* Obvious emphysematous bullae confirmed by chest CT scan\n* Ventricular arrhythmia or myocardial ischemia\n* Severe hemodynamic instability (mean arterial pressure \\\u003C65 mmHg)\n* Severe metabolic acidosis (pH \\\u003C7.20 and bicarbonate \\\u003C22 mmol\u002FL)\n* Refusal to receive NPPV or give informed consent\n* Prior endotracheal intubation or tracheostomy during the current hospitalization\n* A do-not-intubate order","ALL","18 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"NA","To determine whether high-intensity NPPV, compared with low-intensity NPPV, could have an effect on the subjective tolerance in patients with an AECOPD and hypercapnia.",[67],"Acute Exacerbation of Chronic Obstructive Pulmonary Disease","NOT_YET_RECRUITING","2024-11-14",{"date":71,"type":72},"2024-11-18","ACTUAL",{"date":74,"type":61},"2024-12",{"date":76,"type":61},"2025-10",{"name":5,"class":6},1]