[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650533":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":53,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Centre Hospitalier Departemental Vendee","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"tidal volume in spontaneous ventilation and NIV","EXPERIMENTAL",null,[13,14],"Device: Hand-held spirometer","Device: NIV",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DEVICE","Hand-held spirometer","spontaneous ventilation using a hand-held spirometer",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"NIV","NIV with predefined settings and then with optimized settings",[9],[26],{"name":27,"affiliation":28,"role":29},"Gwenhaël COLIN, Dr","Centre Hospitalier Départemental Vendée","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Laura SOULARD","CONTACT","02.51.08.05.82","+33","laura.soulard@chd-vendee.fr",[38],{"facility":39,"status":11,"city":40,"state":11,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Centre Hospitalier Universitaire de Nantes - Hôpital Hôtel Dieu","Nantes","44093","France","FR",{"type":45,"coordinates":46},"Point",[47,48],-1.55336,47.21725,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":11,"phoneExt":11,"email":11},"Jean Baptiste LASCARROU, Dr",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650533","bedside-spirometry-for-acute-lung-injury-100650533",false,"NCT07750717","Bedside Spirometry for Acute Lung Injury","Correlation Between Tidal Volume in Spontaneous Ventilation and Tidal Volume in Non-invasive Ventilation in Acute Hypoxemic Non-hypercapnic Respiratory Failure","SPIRALI","Inclusion Criteria:\n\n* Patient over 18 years of age;\n* Patient hospitalized in intensive care for less than 24 hours;\n* Patient with severe hypoxemic acute respiratory failure characterized by a PaO2\u002FFiO2 ratio \\\u003C 300 mmHg and \\> 150 mmHg under high-flow oxygen therapy at 60 L\u002Fmin;\n* Patient able to cooperate with the spirometry test;\n* Patient able to follow the protocol and having given their informed written consent to participate in the study;\n* Patient affiliated with the social security system or entitled to benefits;\n\nExclusion Criteria:\n\n* Patients with an indication for intubation;\n* Patients with a contraindication for or who refuse NIV;\n* Patients with hemodynamic instability requiring vasopressor support greater than 0.25 μg\u002Fkg\u002Fmin of norepinephrine;\n* Patients with a Glasgow score \\\u003C 15;\n* Patients with hypercapnia (PaCO2 \\> 45 mmHg);\n* Patients with a PaO2\u002FFiO2 ratio \\\u003C 150 mmHg;\n* Patients with cardiogenic pulmonary edema;\n* Patients who have already undergone a session of NIV in intensive care during this stay;\n* Patients with chronic respiratory failure (home oxygen therapy or home non-invasive ventilation (excluding indications solely for sleep apnea syndrome));\n* Patients who have recently had a pneumothorax;\n* Patients who have recently undergone eye surgery (e.g., cataract surgery) or throat surgery;\n* Patients with significant arterial disease: recent heart attack, pulmonary embolism, poorly controlled hypertension despite treatment, etc.\n* Patients already included in the study;\n* Pregnant women, women in labor, or women who are breastfeeding;\n* Patients under guardianship, conservatorship, or deprived of their liberty;\n* Patients under an activated future protection mandate;\n* Patients under family authorization;\n* Patients under judicial protection;","ALL","18 Years",{"count":66,"type":67},30,"ESTIMATED","INTERVENTIONAL",[70],"NA","The diagnosis of Acute Respiratory Distress Syndrome (ARDS) is a syndromic diagnosis that groups together patients who may have very different prognoses and respond differently to the same therapies.\n\nAdditionally, non-invasive ventilation (NIV) has shown highly contrasting results in the early management of ARDS. One of the predictive criteria for NIV failure is an excessively high tidal volume during non-invasive ventilation.\n\nSPIRALI is a pilot study evaluating the relevance of a respiratory physiology parameter, the tidal volume relative to the theoretical ideal body weigh, in the phenotypic classification of non-intubated ARDS patients. In this initial approach, the investigators will compare the tidal volume during high-flow oxygen therapy with the tidal volume obtained under NIV (after applying a settings optimization algorithm). The investigators hypothesize that if tidal volume is linked to each situation, the same patients will exhibit a high tidal volume both during spontaneous ventilation and under NIV.",[73],"Respiratory Insufficiency","NOT_YET_RECRUITING","2026-08-06",{"date":77,"type":78},"2026-08-07","ACTUAL",{"date":80,"type":67},"2026-09-30",{"date":82,"type":67},"2029-01-01",{"name":5,"class":6},1]