[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657681":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":75,"studyPopulation":65,"armGroups":76,"interventions":87,"overallOfficials":92,"centralContacts":96,"locations":104,"responsibleParty":120,"collaborators":65,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":65,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":65,"enrollmentInfo":131,"targetDuration":65,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":106,"whyStopped":65,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":65},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of hypoxemia during the oxygen delivery periods","Hypoxemia is defined as peripheral oxygen saturation (SpO2) \\\u003C90% sustained for at least 10 seconds, or an oxygenation index (PaO2\u002FFiO2 ratio) \\\u003C300 mmHg measured by arterial blood gas analysis at minute 10 of the intervention period. The outcome is reported as the proportion of participants experiencing hypoxemia during the nasal oxygen delivery period compared with the transoral oxygen delivery period.","During each 10-minute oxygen delivery period in the PACU (each participant undergoes two consecutive intervention periods)",[14,18,22,26,30,34,37,40,44,47,51,54,57,61],{"measure":15,"description":16,"timeFrame":17},"Incidence of SpO2 \u003C92%","Proportion of participants with peripheral oxygen saturation (SpO2) \\\u003C92% at any time during each oxygen delivery period.","During each 10-minute oxygen delivery period in the PACU",{"measure":19,"description":20,"timeFrame":21},"Oxygenation index (PaO2\u002FFiO2 ratio)","Calculated from arterial blood gas sampled through the indwelling radial arterial catheter at minute 10 of each intervention period; compared between the nasal and transoral oxygen delivery periods.","At minute 10 of each 10-minute oxygen delivery period",{"measure":23,"description":24,"timeFrame":25},"Time to achieve SpO2 >=95%","Time elapsed from the beginning of each intervention until peripheral oxygen saturation reaches \\>=95%.","From the start of each oxygen delivery period, up to 10 minutes",{"measure":27,"description":28,"timeFrame":29},"Proportion of participants requiring escalation of oxygen therapy","Proportion of participants requiring escalation to a simple face mask (\\>=6 L\u002Fmin), reservoir mask, high-flow nasal cannula (HFNC), or noninvasive ventilation (NIV) because of SpO2 \\\u003C90% or respiratory distress.","Throughout the PACU stay (up to 24 hours after surgery)",{"measure":31,"description":32,"timeFrame":33},"Respiratory rate","Respiratory rate (breaths\u002Fmin) recorded at each predefined time point.","Preoperatively; at the start of surgery; at the end of surgery; after extubation; 1 minute before and 1 minute after each change of oxygen delivery route; at PACU discharge",{"measure":35,"description":36,"timeFrame":33},"Heart rate","Heart rate (beats\u002Fmin) recorded at each predefined time point.",{"measure":38,"description":39,"timeFrame":33},"Mean arterial pressure (MAP)","Mean arterial pressure (mmHg) recorded at each predefined time point.",{"measure":41,"description":42,"timeFrame":43},"Airway plateau pressure","Airway plateau pressure (cmH2O) recorded from the anesthesia ventilator.","At the start and at the end of surgery",{"measure":45,"description":46,"timeFrame":43},"Positive end-expiratory pressure (PEEP)","Positive end-expiratory pressure (cmH2O) recorded from the anesthesia ventilator.",{"measure":48,"description":49,"timeFrame":50},"Oral dryness score","Oral dryness assessed with a visual analog scale (VAS) ranging from 0 to 10, where 0 indicates no dryness and 10 indicates the worst imaginable dryness. Higher scores indicate worse (more severe) dryness.","Immediately after completion of each 10-minute oxygen delivery period",{"measure":52,"description":53,"timeFrame":50},"Overall comfort score","Overall comfort assessed with a visual analog scale (VAS) ranging from 0 to 10, where 0 indicates maximal discomfort and 10 indicates maximal comfort. Higher scores indicate better comfort.",{"measure":55,"description":56,"timeFrame":50},"Pharyngeal irritation \u002F nausea score","Patient-reported pharyngeal irritation and nausea, each graded on a 4-point scale: 0 = none, 1 = mild (symptoms present but tolerable), 2 = moderate (causing discomfort but not requiring intervention), 3 = severe (requiring intervention). Higher scores indicate worse symptoms.",{"measure":58,"description":59,"timeFrame":60},"Length of PACU stay","Total duration of stay in the postanesthesia care unit, in minutes.","From PACU admission to PACU discharge (up to 24 hours after surgery)",{"measure":62,"description":63,"timeFrame":64},"Respiratory complications within 24 hours after surgery","Composite of reintubation, pneumonia, atelectasis, and requirement for prolonged oxygen therapy, reported as the number and proportion of participants with each event.","Within 24 hours after surgery",null,{"allocation":67,"interventionModel":68,"interventionModelDescription":65,"primaryPurpose":69,"observationalModel":65,"timePerspective":65,"maskingInfo":70},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":71,"maskingDescription":72,"whoMasked":73},"SINGLE","Blinding of participants and care providers is not feasible because the position of the nasal cannula (nasal versus transoral) is visually identifiable during the intervention.",[74],"OUTCOMES_ASSESSOR","This is a single-center, randomized, controlled, crossover trial conducted in the Department of Anesthesiology, Pain and Perioperative Medicine, Nanjing First Hospital, Nanjing Medical University, China.\n\nScreening and assessment of mouth breathing: Adult patients recovering from general anesthesia for elective thoracic or abdominal surgery are assessed 5 minutes after tracheal extubation using a standardized three-step procedure: (1) visual screening (lip separation \\>0.5 cm, visible anterior teeth, and lowered mandibular position, observed for 0-10 s); (2) airflow verification using cotton fiber wisps placed approximately 1 cm in front of both nostrils and the lips to identify the dominant ventilation pathway (10-25 s); and (3) mirror confirmation of exhaled vapor condensation together with observation of tongue position (25-40 s). Persistent mouth breathing is confirmed when all three steps are positive and no spontaneous mouth closure lasting more than 3 seconds occurs during the 40-second observation period.\n\nInterventions: (a) Standard nasal cannula oxygen delivery: a standard dual-prong nasal cannula is placed in both nostrils with an oxygen flow of 4 L\u002Fmin for 10 minutes. (b) Transoral nasal cannula oxygen delivery: the two prongs of the same nasal cannula are joined and placed in the oral vestibule at the inner aspect of the mouth corner (approximately at the buccal mucosa corresponding to the first molar), to a depth of no more than 3 cm, with an oxygen flow of 4 L\u002Fmin for 10 minutes. A 5-minute washout period, during which nasal oxygen delivery is resumed, separates the two intervention periods.\n\nRandomization and sequence: Eligible participants are randomly assigned in a 1:1 ratio to one of two sequences. Sequence A (nasal first): nasal oxygen delivery for 10 minutes, 5-minute washout, then transoral oxygen delivery for 10 minutes. Sequence B (transoral first): transoral oxygen delivery for 10 minutes, 5-minute washout, then nasal oxygen delivery for 10 minutes.\n\nMeasurements: SpO2 is monitored continuously throughout all periods. Arterial blood gas is sampled at minute 10 of each intervention period through the indwelling radial arterial catheter placed for routine intraoperative monitoring (approximately 1 mL per sample) to calculate the oxygenation index (PaO2\u002FFiO2 ratio). Vital signs, comfort scores, and adverse effects are recorded at predefined time points.\n\nSafety management: Continuous pulse oximetry is maintained throughout the study. Predefined safety exit criteria are applied (e.g., SpO2 \\\u003C85% sustained for more than 2 minutes, or SpO2 \\\u003C88% during any intervention); oxygen therapy is escalated immediately (face mask, reservoir mask, high-flow nasal cannula, or noninvasive ventilation) whenever clinically indicated, and an anesthesiologist is present in the PACU at all times. The same cannula is disinfected with cotton swabs when switched between the nasal and oral routes to prevent cross-infection.",[77,83],{"label":78,"type":79,"description":80,"interventionNames":81},"Sequence ON: Transoral oxygen first, then nasal oxygen","ACTIVE_COMPARATOR","Participants receive transoral nasal cannula oxygen delivery (4 L\u002Fmin for 10 minutes), followed by a 5-minute washout period (nasal oxygen delivery resumed), and then standard nasal cannula oxygen delivery (4 L\u002Fmin for 10 minutes).",[82],"Other: Transoral nasal cannula oxygen delivery",{"label":84,"type":79,"description":85,"interventionNames":86},"Sequence NO: Nasal oxygen first, then transoral oxygen","Participants receive standard nasal cannula oxygen delivery (4 L\u002Fmin for 10 minutes), followed by a 5-minute washout period (nasal oxygen delivery resumed), and then transoral nasal cannula oxygen delivery (4 L\u002Fmin for 10 minutes).",[82],[88],{"type":6,"name":89,"description":90,"armGroupLabels":91,"otherNames":65},"Transoral nasal cannula oxygen delivery","The two prongs of a standard dual-prong nasal cannula are joined and placed in the oral vestibule at the inner aspect of the mouth corner (approximately at the buccal mucosa corresponding to the first molar), to a depth of no more than 3 cm to avoid stimulating the gag reflex. Oxygen flow is set at 4 L\u002Fmin with standard humidification for 10 minutes.",[84,78],[93],{"name":94,"affiliation":5,"role":95},"Shuai Wang","PRINCIPAL_INVESTIGATOR",[97,101],{"name":94,"role":98,"phone":99,"phoneExt":65,"email":100},"CONTACT","+8618852095101","wangshuaisj@126.com",{"name":102,"role":98,"phone":103,"phoneExt":65,"email":65},"YING ZHANG","025-52271064",[105],{"facility":5,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"RECRUITING","Nanjing","Jaingsu","210006","China","CN",{"type":113,"coordinates":114},"Point",[115,116],118.77778,32.06167,{"lat":116,"lon":115},[119],{"name":94,"role":98,"phone":99,"phoneExt":65,"email":100},{"type":95,"investigatorFullName":94,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Deputy Chief Nurse","100657681","transoral-nasal-cannula-oxygen-therapy-for-mouth-breathing-patients-in-the-postanesthesia-care-unit-100657681",false,"NCT07841223","Transoral Nasal Cannula Oxygen Therapy for Mouth-Breathing Patients in the Postanesthesia Care Unit","Transoral Nasal Cannula Oxygen Delivery on Postoperative Hypoxemia for Mouth-breathing Patients After Surgery: a Randomized Controlled Crossover Trial","Inclusion Criteria:\n\n1. Aged older than 18 years;\n2. American Society of Anesthesiologists (ASA) physical status classification I-III;\n3. Undergoing elective thoracic or abdominal surgery under general anesthesia with postoperative transfer to the postanesthesia care unit (PACU);\n4. Anticipated PACU stay of at least 30 minutes to allow an adequate observation window for data collection;\n5. Recovery of spontaneous breathing after tracheal extubation, and confirmed as persistent mouth breathing by the standardized three-step assessment procedure (visual screening, cotton-fiber airflow verification, and mirror confirmation);\n6. Written informed consent signed by the patient or a family member.\n\nExclusion Criteria:\n\n1. Preoperative diagnosis of severe obstructive sleep apnea-hypopnea syndrome (apnea-hypopnea index \\[AHI\\] \\>30) or requirement for continuous positive airway pressure therapy;\n2. Severe hypoxemia requiring immediate escalation of oxygen therapy (SpO2 \\\u003C90% or PaO2 \\\u003C60 mmHg);\n3. Requirement for reintubation or placement of an oropharyngeal or nasopharyngeal airway after surgery;\n4. Hemodynamic instability requiring vasoactive agents to maintain mean arterial pressure (MAP \\\u003C65 mmHg).","ALL","18 Years",{"count":132,"type":133},64,"ESTIMATED","INTERVENTIONAL",[136],"NA","Postoperative hypoxemia is a common complication in the postanesthesia care unit (PACU). Patients who breathe through the mouth after tracheal extubation may receive limited benefit from standard nasal cannula oxygen therapy, because the nasal cavity functions as an ineffective dead space during mouth breathing. Clinical observations suggest that placing the prongs of a nasal cannula inside the mouth (transoral oxygen delivery) rapidly improves oxygenation in these patients. However, no randomized controlled trial has formally verified this effect.\n\nThis single-center, randomized, controlled, crossover trial will enroll 64 adult patients identified as persistent mouth breathers after extubation in the PACU following elective thoracic or abdominal surgery under general anesthesia. Each participant will receive, in a randomized sequence, both standard nasal cannula oxygen delivery (4 L\u002Fmin for 10 minutes) and transoral nasal cannula oxygen delivery (4 L\u002Fmin for 10 minutes), separated by a 5-minute washout period, so that each participant serves as his or her own control.\n\nThe primary outcome is the incidence of hypoxemia (peripheral oxygen saturation \\[SpO2\\] \\\u003C90% sustained for at least 10 seconds, or oxygenation index \\[PaO2\u002FFiO2 ratio\\] \\\u003C300 mmHg) during each oxygen delivery period. Secondary outcomes include the incidence of SpO2 \\\u003C92%, time to achieve SpO2 \\>=95%, oxygenation index measured by arterial blood gas analysis, need for escalation of oxygen therapy, vital signs, patient comfort and adverse effects, PACU length of stay, and respiratory complications within 24 hours after surgery. The results are expected to provide high-level evidence for optimizing oxygen therapy strategies for mouth-breathing patients in the PACU.",[139],"Postoperative Hypoxemia",[141,142,143,144,145,146,147],"Nasal cannula","Transoral oxygen delivery","Postanesthesia care unit (PACU)","Oxygen therapy","Crossover trial","Pulse oximetry (SpO2)","Oxygenation index","2026-10-08",{"date":150,"type":151},"2026-10-09","ACTUAL",{"date":148,"type":151},{"date":154,"type":133},"2027-12-31",{"name":5,"class":6},1]