Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06459167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Position Intervention to Reduce Hypoxemia in Sedation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D056151', 'term': 'Airway Remodeling'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1752}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lowest SpO2', 'timeFrame': 'During procedure', 'description': 'The lowest SpO2 during sedation and procedures'}, {'measure': 'Use of airway interventions', 'timeFrame': 'During procedure', 'description': 'Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation'}], 'secondaryOutcomes': [{'measure': 'The onset of when SpO2 dropped below 80%', 'timeFrame': 'During procedure', 'description': 'The onset of when SpO2 reached below 80%'}, {'measure': 'The onset of when SpO2 dropped below 70%', 'timeFrame': 'During procedure', 'description': 'The onset of when SpO2 reached below 70%'}, {'measure': 'The onset of respiratory adverse events', 'timeFrame': 'During procedure', 'description': 'The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation'}, {'measure': 'The onset of circulatory adverse events', 'timeFrame': 'During procedure', 'description': 'The onset of circulatory adverse events including hypotension, hypertension, bradycardia, tachycardia, new-onset arrhythmia with hemodynamically stable/instability, cardiac arrest, shock'}, {'measure': 'The onset of gastrointestinal adverse events', 'timeFrame': 'During procedure', 'description': 'The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation'}, {'measure': 'The degree of operator satisfaction', 'timeFrame': 'During procedure', 'description': 'The degree of operator satisfaction regarding the performance, effectiveness, and experience of a procedure. A 10-point scale is used, 0 indicates complete dissatisfaction and 10 indicates complete satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['position', 'hypoxemia', 'sedation', 'emergency', 'upper airway'], 'conditions': ['Hypoxemia', 'Sedation Complication', 'Emergencies', 'Airway Remodeling']}, 'referencesModule': {'references': [{'pmid': '26126161', 'type': 'BACKGROUND', 'citation': 'Klare P, Huth R, Haller B, Huth M, Weber A, Schlag C, Reindl W, Schmid RM, von Delius S. Patient position and hypoxemia during propofol sedation for colonoscopy: a randomized trial. Endoscopy. 2015 Dec;47(12):1159-66. doi: 10.1055/s-0034-1392329. Epub 2015 Jun 30.'}, {'pmid': '37957962', 'type': 'RESULT', 'citation': "Ababneh O, Bsisu I, El-Share' AI, Alrabayah M, Qudaisat I, Alghanem S, Khreesha L, Ali AM, Rashdan M. Awake Nasal Fiberoptic Intubation in Lateral Position for Severely Obese Patients with Anticipated Difficult Airway: A Randomized Controlled Trial. Healthcare (Basel). 2023 Oct 24;11(21):2818. doi: 10.3390/healthcare11212818."}, {'pmid': '12502975', 'type': 'RESULT', 'citation': 'Edmark L, Kostova-Aherdan K, Enlund M, Hedenstierna G. Optimal oxygen concentration during induction of general anesthesia. Anesthesiology. 2003 Jan;98(1):28-33. doi: 10.1097/00000542-200301000-00008.'}, {'pmid': '28487139', 'type': 'RESULT', 'citation': 'Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.'}, {'pmid': '33070582', 'type': 'RESULT', 'citation': 'Wahdan AS, El-Refai NAR, Omar SH, Abdel Moneem SA, Mohamed MM, Hussien MM. Endotracheal intubation in patients undergoing open abdominal surgery in the lateral position: a comparison between the intubating video stylet and fiberoptic intubating bronchoscopy. Korean J Anesthesiol. 2021 Jun;74(3):234-241. doi: 10.4097/kja.20384. Epub 2020 Oct 19.'}, {'pmid': '38458110', 'type': 'RESULT', 'citation': 'Leeb G, Auchus I, Law T, Bickler P, Feiner J, Hashi S, Monk E, Igaga E, Bernstein M, Chou YC, Hughes C, Schornack D, Lester J, Moore K Jr, Okunlola O, Fernandez J, Shmuylovich L, Lipnick M. The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigment. EBioMedicine. 2024 Apr;102:105051. doi: 10.1016/j.ebiom.2024.105051. Epub 2024 Mar 8.'}, {'pmid': '40829895', 'type': 'DERIVED', 'citation': 'Ye H, Chu LH, Xie GH, Hua YJ, Lou Y, Wang QH, Xu ZX, Tang MY, Wang BD, Hu HY, Ying J, Yu T, Wang HY, Wang Y, Ye ZJ, Bao XF, Wang MC, Chen LY, Wang XX, Zhang XB, Huang CS, Wang J, Lu YP, Luo FQ, Zhou W, Wang CG, Cheng H, Liu WJ, Luo J, Wu YQ, Li RR, Wang D, Hou LQ, Shi L, Zhang J, Wang K, Pi X, Zhou R, Yang QQ, Wan PL, Li H, Wu SJ, Song SW, Cui P, Shu L, Islam N, Fang XM. Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial. BMJ. 2025 Aug 19;390:e084539. doi: 10.1136/bmj-2025-084539.'}]}, 'descriptionModule': {'briefSummary': "Hypoxemia was defined as an SpO2 of \\< 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple interventions by changing position to maintain patients' respiratory function can be more economical, convenient and safe.", 'detailedDescription': "Hypoxemia was defined as an SpO2 of \\< 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple positional interventions to maintain patients' respiratory function can be more economical, convenient and safe. This study aims to conduct a prospective, multicenter, randomized controlled trial to observe the level of patients' oxygen saturation and the occurrence of hypoxemia under different body positions (supine and lateral positions), and its impact on prognosis, providing reliable evidence-based medical evidence for the prevention and treatment of complications in patients requiring airway management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with 18 years or older\n2. Without obvious cardiovascular or pulmonary dysfunction\n3. Scheduled to undergo procedure or surgery with sedation\n4. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Preexisting bradycardia (heart rate \\<50 beats/min), hypotension (systolic blood pressure \\< 80mmHg), or hypoxemia (SpO2 \\< 90%);\n2. Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases\n3. Preexisting diseases which unable to tolerate reduced SpO2 or Partial pressure of carbon dioxide in artery (PaCO2) diseases, such as severe cardiovascular and cerebrovascular diseases, intracranial hypertension or severe lung diseases;\n4. Coagulation disorders or a tendency of nose bleeding;\n5. Patients whose body position cannot be altered;\n6. Participated in other intervention clinical studies in the past 3 months;\n7. Other conditions deemed unsuitable for inclusion by the researcher;\n8. Patients and guardians refused to participate in this trial.'}, 'identificationModule': {'nctId': 'NCT06459167', 'briefTitle': 'Position Intervention to Reduce Hypoxemia in Sedation Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Position Intervention to Reduce Hypoxemia in Sedation Patients', 'orgStudyIdInfo': {'id': 'Hypoxemia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group S', 'description': 'Patients needing sedation for procedure or surgery are assisted into supine position before they were sedated and kept during the procedure.', 'interventionNames': ['Other: The position adopted when patients undergoing procedure or surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Group L', 'description': 'Patients needing sedation for procedure or surgery are assisted into lateral position before they were sedated and kept the procedure.', 'interventionNames': ['Other: The position adopted when patients undergoing procedure or surgery']}], 'interventions': [{'name': 'The position adopted when patients undergoing procedure or surgery', 'type': 'OTHER', 'description': 'For patients requiring sedation for procedures or surgery, they are randomly assigned either to supine position or lateral position before they are sedated, and kept during procedure or surgery.', 'armGroupLabels': ['Group L', 'Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Hui Ye, M.D.', 'role': 'CONTACT', 'email': 'yehui@zju.edu.cn', 'phone': '8615267048716'}, {'name': 'Xiangming Fang, M.D.', 'role': 'CONTACT', 'email': 'xmfang@zju.edu.cn', 'phone': '8613857161019'}], 'overallOfficials': [{'name': 'Xiangming Fang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang Provincial Tongde Hospital', 'class': 'OTHER'}, {'name': "Shenzhen Second People's Hospital", 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The Sixth Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Lishui Municipal Central Hospital', 'class': 'OTHER_GOV'}, {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, {'name': 'Zunyi Medical College', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor', 'investigatorFullName': 'xiangming fang', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}