Position Intervention to Reduce Hypoxemia in Sedation Patients

NCT06459167 | Not Yet Recruiting

• 1 other identifier: Hypoxemia
• Study Type: interventional
• Target: 1,752
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxemia; Sedation Complication; Emergencies; Airway Remodeling

Keywords

position; hypoxemia; sedation; emergency; upper airway

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• The onset of when SpO2 dropped below 80%

  During procedure

• The onset of when SpO2 dropped below 70%

  During procedure

• The onset of respiratory adverse events

  During procedure

• The onset of circulatory adverse events

  During procedure

• The onset of gastrointestinal adverse events

  During procedure

Study Arms (2)

Group S

EXPERIMENTAL

Patients needing sedation for procedure or surgery are assisted into supine position before they were sedated and kept during the procedure.

Other: The position adopted when patients undergoing procedure or surgery

Group L

EXPERIMENTAL

Patients needing sedation for procedure or surgery are assisted into lateral position before they were sedated and kept the procedure.

Other: The position adopted when patients undergoing procedure or surgery

Interventions

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.

Group L; Group S

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 18 years or older
• Without obvious cardiovascular or pulmonary dysfunction
• Scheduled to undergo procedure or surgery with sedation
• Signed the informed consent form

You may not qualify if:

• Preexisting bradycardia (heart rate \<50 beats/min), hypotension (systolic blood pressure \< 80mmHg), or hypoxemia (SpO2 \< 90%);
• Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases
• 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;
• Coagulation disorders or a tendency of nose bleeding;
• Patients whose body position cannot be altered;
• Participated in other intervention clinical studies in the past 3 months;
• Patients and guardians refused to participate in this trial.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• The Sixth Affiliated Hospital of Wenzhou Medical University: collaborator
• Lishui Municipal Central Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator
• Zunyi Medical College: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (7)

• 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: 26126161 BACKGROUND

• 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: 37957962 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.

  PMID: 12502975 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.

  PMID: 28487139 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.

  PMID: 33070582 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.

  PMID: 38458110 RESULT

• 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.

  PMID: 40829895 DERIVED

MeSH Terms

Conditions

Hypoxia; Emergencies; Airway Remodeling

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Pathological Conditions, Anatomical

Study Officials

• Xiangming Fang, M.D.

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Ye, M.D.

CONTACT

8615267048716; yehui@zju.edu.cn

Xiangming Fang, M.D.

CONTACT

8613857161019; xmfang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 14, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)