[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656658":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":54,"studyPopulation":42,"armGroups":55,"interventions":81,"overallOfficials":95,"centralContacts":100,"locations":42,"responsibleParty":109,"collaborators":112,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":42,"enrollmentInfo":132,"targetDuration":42,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":151,"whyStopped":42,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":42},{"fullName":5,"class":6},"University Hospital Ulm","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Occurrence of at least one postoperative pulmonary complication","The primary outcome is a composite endpoint of postoperative pulmonary complications. It is met if a participant experiences at least one predefined postoperative pulmonary complication and their severity is graded according to the Clavien-Dindo-Classification","Postoperative day one until hospital discharge or postoperative day 28, whichever occurs earlier",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Intraoperative complications","The classification of intraoperative adverse events (ClassIntra), ranging from grade 0 to grade V. It is used to assess intraoperative anaesthesia- and surgery-related complications.","During the surgery",{"measure":19,"description":20,"timeFrame":21},"Critical respiratory events in the recovery room","The outcome is met if at least one predefined critical respiratory event occurs. Events include upper airway obstruction requiring intervention, hypoxaemia not responding to active interventions, signs of respiratory distress or impending ventilatory failure, inability to breathe deeply, symptoms of respiratory or upper-airway muscle weakness, suspected pulmonary aspiration, or reintubation.","During post-anesthesia care before admission to the normal ward",{"measure":23,"description":24,"timeFrame":25},"Any postoperative in-hospital complication","Postoperative complications are recorded during the hospital stay during predefined visits in accordance with the postoperative morbidity survey including pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound and pain). If a complication occurs each complication is categorized according to the Clavien-Dindo classification.","Patients are visited on postoperative days 1 and 3 to 4 in person and on the day of discharge from hospital or day 28 (whatever occurs first) via chart review to document complications between the current and the last assessment.",{"measure":27,"description":28,"timeFrame":29},"Surgical conditions","Surgical conditions will be assessed in a single-blinded manner via the Leiden Surgical Rating Scale which ranges from 1 to 5, with 1 indicating extremely poor surgical conditions and 5 indicating optimal surgical conditions considering visibility, surgical space, muscle contractions, handling tactics and patient movement.","During surgery, assessed every 15 minutes",{"measure":31,"description":32,"timeFrame":33},"Quality of Recovery questionnaire","The Quality of Recovery 15 questionnaire will be assessed and consists of 15 items to determine subjective recovery after surgery on an 11-point Likert scale (0-10) summing to a maximum of 150 points with greater sum representing better recovery.","On postoperative day 1, day of discharge or on day 28 whatever occurs first and on postoperative day 180",{"measure":35,"description":36,"timeFrame":37},"Functional Health","The WHODAS-2 (World Health Organization Disability Assessment Schedule 2.0) scale will be used to quantify the level of disability ranging from 0 (no difficulty) to 42 (great difficulty) within the last 30 days.","During pre-admission testing and 180 days after surgery",{"measure":39,"description":40,"timeFrame":41},"Further Outcomes","Length of hospital stay, length of intensive care unit stay and 180-day mortality.","Retrieved from Chart Review or at the 180 day follow-up",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","This is a randomized, controlled, parallel-group trial with three study groups. Participants are allocated to tracheal tube management with neuromuscular blockade (TT\u002FNMB), supraglottic airway device management with neuromuscular blockade (SGA\u002FNMB), or supraglottic airway device management without neuromuscular blockade (SGA\u002Fno NMB). Allocation occurs in an unequal ratio of 1:2.9:2.9. Patients receiving NMB are additionally allocated 1:1 to receive either deep or moderate neuromuscular blockade.","PREVENTION",{"masking":49,"maskingDescription":50,"whoMasked":51},"DOUBLE","Participants and outcome assessors will be blinded to treatment allocation. The intraoperative anaesthesia team and personnel responsible for intraoperative trial conduct will be unblinded.",[52,53],"PARTICIPANT","OUTCOMES_ASSESSOR","SupAIR is an international, multicenter, randomized, controlled, parallel-group clinical trial evaluating the effects of airway management and neuromuscular blockade (NMB) on postoperative pulmonary complications after general anesthesia.\n\nA total of 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms:\n\n1. Tracheal tube with moderate NMB\n2. Tracheal tube with deep NMB\n3. Supraglottic airway device with moderate NMB\n4. Supraglottic airway device with deep NMB\n5. Supraglottic airway device without NMB\n\nThe five treatment arms result from an initial allocation to tracheal tube with NMB, supraglottic airway device with NMB, or supraglottic airway device without NMB. Participants assigned to NMB are additionally randomized to moderate or deep neuromuscular blockade.\n\nThe study addresses two primary hypotheses. First, among participants receiving NMB, use of a supraglottic airway device is hypothesized to reduce postoperative pulmonary complications compared with tracheal intubation. Second, among participants managed with a supraglottic airway device, the use of NMB is hypothesized not to increase postoperative pulmonary complications compared with no NMB. Finally, among participants receiving NMB depth of neuromuscular blockade will be used as secondary exposure.\n\nThe randomized intervention determines airway management and the use and depth of neuromuscular blockade. Quantitative neuromuscular monitoring is used in participants receiving NMB, and recovery from neuromuscular blockade is managed according to applicable clinical guidelines. All other aspects of perioperative anesthetic management are performed according to local clinical practice.\n\nThe primary outcome is the occurrence of at least one postoperative pulmonary complication from postoperative day 1 until hospital discharge or postoperative day 28, whichever occurs first. The composite includes respiratory failure, suspected pulmonary infection, pulmonary infiltrates, atelectasis, aspiration pneumonitis, bronchospasm, and pulmonary oedema.\n\nPostoperative outcomes are assessed by blinded study personnel during the hospital stay. Secondary outcomes include intraoperative and postoperative complications, respiratory events in the post-anesthesia care unit, surgical conditions, quality of recovery, functional health, length of stay, intensive care treatment, and mortality. Participants are additionally followed by telephone approximately six months after surgery.\n\nAn interim analysis is planned after approximately 1,000 participants to assess assumptions relevant to sample-size planning. Interim results will be reviewed by the independent Data and Safety Monitoring Board, and the total sample size may be adjusted in accordance with the prespecified analysis plan.",[56,63,69,73,77],{"label":57,"type":58,"description":59,"interventionNames":60},"Tracheal Tube with moderate Neuromuscular Blockade (TT\u002Fmoderate NMB)","ACTIVE_COMPARATOR","General anesthesia with tracheal tube management and moderate neuromuscular blockade.",[61,62],"Procedure: Airway management strategy","Other: Deep versus moderate neuromuscular blockade (NMB)",{"label":64,"type":65,"description":66,"interventionNames":67},"Supraglottic Airway Device with deep Neuromuscular Blockade (SGA\u002Fdeep NMB)","EXPERIMENTAL","General anesthesia with supraglottic airway device management and deep neuromuscular blockade.",[61,68,62],"Procedure: Initiation of neuromuscular blockade (NMB)",{"label":70,"type":58,"description":71,"interventionNames":72},"Supraglottic Airway Device without Neuromuscular Blockade (SGA\u002Fno NMB)","General anaesthesia with supraglottic airway device management without neuromuscular blockade.",[68],{"label":74,"type":58,"description":75,"interventionNames":76},"Tracheal Tube with deep Neuromuscular Blockade (TT\u002Fdeep NMB)","General anesthesia with tracheal tube management and deep neuromuscular blockade.",[61,62],{"label":78,"type":65,"description":79,"interventionNames":80},"Supraglottic Airway Device with moderate Neuromuscular Blockade (SGA\u002Fmoderate NMB)","General anesthesia with supraglottic airway device management and moderate neuromuscular blockade.",[61,68,62],[82,87,91],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":42},"PROCEDURE","Airway management strategy","For the superiority hypothesis the placement of the supraglottic airway device compared to the endotracheal tube is investigated.",[64,78,74,57],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":42},"Initiation of neuromuscular blockade (NMB)","For the non-inferiority hypothesis the initiation of neuromuscular blockade in patients receiving a supraglottic airway is investigated.",[64,78,70],{"type":6,"name":92,"description":93,"armGroupLabels":94,"otherNames":42},"Deep versus moderate neuromuscular blockade (NMB)","Deep or moderate NMB. Muscle relaxants are administered according to group allocation. Repetitive doses of half the ED95s are administered at Train-of-Four (TOF) count ≥ 2 in the moderate group and at post-tetanic count (PTC) ≥ 2 in the deep blockade group.",[64,78,74,57],[96],{"name":97,"affiliation":98,"role":99},"Manfred Blobner, Professor M.D.","Department of Anesthesiology and Intensive Care Medicine, Ulm University Hospital, Ulm, Germany","PRINCIPAL_INVESTIGATOR",[101,106],{"name":102,"role":103,"phone":104,"phoneExt":42,"email":105},"Béla-Simon Paschold, M.D. Coordinating Investigator","CONTACT","+49 731 50060390","bela-simon.paschold@uni-ulm.de",{"name":107,"role":103,"phone":108,"phoneExt":42,"email":42},"Clinical Research Physician","+49 731 50054306",{"type":99,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Manfred Blobner","Principal Investigator, Professor of Anesthesiology and Intensive Care Medicine",[113,115,117,119,121],{"name":114,"class":6},"Medical University of Vienna",{"name":116,"class":6},"Universitätsmedizin Mannheim",{"name":118,"class":6},"Klinikum Oldenburg gGmbH",{"name":120,"class":6},"University Hospital, Zürich",{"name":122,"class":6},"St. Josef Hospital Bochum","100656658","postoperative-pulmonary-complications-after-use-of-supraglottic-airway-devices-and-neuromuscular-blockade-100656658",false,"NCT07829094","Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade","SupAIR","Inclusion Criteria:\n\nAdult patients (≥ 18 years) with an ASA physical status ≤ 3 scheduled for elective non-cardiac surgery under general anaesthesia whose airway can be secured via tracheal tube or SGA.\n\nExclusion Criteria:\n\nContraindications for using supraglottic devices, tracheal tube, or neuromuscular blocking agents (and reversal drugs); surgery in prone positioning; surgical procedures scheduled outside the operating room; ambulatory surgery; pregnancy; patients planned for consecutive anaesthetic\u002Fsurgical procedures in the following 14 days or within the past 14 days.","ALL","18 Years",{"count":133,"type":134},6800,"ESTIMATED","INTERVENTIONAL",[137],"NA","SupAIR is an international, multicenter, randomized controlled trial investigating whether airway management and neuromuscular blockade during general anesthesia influence postoperative pulmonary complications.\n\nApproximately 6,800 adults undergoing elective non-cardiac surgery will be randomized to one of five treatment arms: tracheal intubation with moderate neuromuscular blockade, tracheal intubation with deep neuromuscular blockade, supraglottic airway with moderate neuromuscular blockade, supraglottic airway with deep neuromuscular blockade, or supraglottic airway without neuromuscular blockade.\n\nThe primary outcome is the occurrence of postoperative pulmonary complications during the hospital stay. Secondary outcomes include perioperative complications, surgical conditions, recovery, and functional health. Participants will be followed during hospitalization and again approximately six months after surgery.",[140],"Postoperative Pulmonary Complications",[142,143,144,145,146,27,147,148,149,150],"Postoperative Complications","Laryngeal Masks","Intubation","Endotracheal Tube","Neuromuscular Blockade","Postoperative pulmonary complications","PPC","Anesthesia","Supraglottic airway","NOT_YET_RECRUITING","2026-09-30",{"date":154,"type":155},"2026-10-05","ACTUAL",{"date":157,"type":134},"2026-10-15",{"date":159,"type":134},"2030-09-01",{"name":5,"class":6}]