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| Name | Class |
|---|---|
| Zhejiang Provincial Tongde Hospital | OTHER |
| Shenzhen Second People's Hospital | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| The Sixth Affiliated Hospital of Wenzhou Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group S | Experimental | Patients needing sedation for procedure or surgery are assisted into supine position before they were sedated and kept during the procedure. |
|
| Group L | Experimental | Patients needing sedation for procedure or surgery are assisted into lateral position before they were sedated and kept the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The position adopted when patients undergoing procedure or surgery | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The lowest SpO2 | The lowest SpO2 during sedation and procedures | During procedure |
| Use of airway interventions | Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The onset of when SpO2 dropped below 80% | The onset of when SpO2 reached below 80% | During procedure |
| The onset of when SpO2 dropped below 70% | The onset of when SpO2 reached below 70% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Ye, M.D. | Contact | 8615267048716 | yehui@zju.edu.cn | |
| Xiangming Fang, M.D. | Contact | 8613857161019 | xmfang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiangming Fang, M.D. | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26126161 | Background | 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. | |
| 37957962 | Result | 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. |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D004630 | Emergencies |
| D056151 | Airway Remodeling |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Lishui Municipal Central Hospital | OTHER_GOV |
| Ningbo No. 1 Hospital | OTHER |
| Zunyi Medical College | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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| During procedure |
| The onset of respiratory adverse events | The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation | During procedure |
| The onset of circulatory adverse events | The onset of circulatory adverse events including hypotension, hypertension, bradycardia, tachycardia, new-onset arrhythmia with hemodynamically stable/instability, cardiac arrest, shock | During procedure |
| The onset of gastrointestinal adverse events | The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation | During procedure |
| The degree of operator satisfaction | 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. | During procedure |
| 12502975 | Result | 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. |
| 28487139 | Result | 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. |
| 33070582 | Result | 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. |
| 38458110 | Result | 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. |
| 40829895 | Derived | 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. |
| D010335 | Pathologic Processes |
| D020763 | Pathological Conditions, Anatomical |