Position Intervention to Reduce Hypoxemia in Sedation Patients

Emergencies Clinical Trial

Official title:

Position Intervention to Reduce Hypoxemia in Sedation Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459167
• Other study ID #: Hypoxemia
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hui Ye, M.D.
• Phone: 8615267048716
• Email: yehui[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1752
• Est. completion date: June 30, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with 18 years or older

2. Without obvious cardiovascular or pulmonary dysfunction

3. Scheduled to undergo procedure or surgery with sedation

4. Signed the informed consent form

Exclusion Criteria:

1. Preexisting bradycardia (heart rate <50 beats/min), hypotension (systolic blood pressure < 80mmHg), or hypoxemia (SpO2 < 90%);

2. Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases

3. 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;

4. Coagulation disorders or a tendency of nose bleeding;

5. Patients whose body position cannot be altered;

6. Participated in other intervention clinical studies in the past 3 months;

7. Other conditions deemed unsuitable for inclusion by the researcher;

8. Patients and guardians refused to participate in this trial.

Related Conditions & MeSH terms

• Airway Remodeling
• Emergencies
• Hypoxemia
• Hypoxia
• Sedation Complication

Intervention

Other:
• The position adopted when patients undergoing procedure or surgery
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (9)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Lishui Municipal Central Hospital, Ningbo No. 1 Hospital, Shenzhen Second People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Sixth Affiliated Hospital of Wenzhou Medical University, Zhejiang Provincial People's Hospital, Zhejiang Provincial Tongde Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Healt — View 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. — View 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. — View 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 — View 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 S — View 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 bronchosco — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The lowest SpO2	The lowest SpO2 during sedation and procedures	During procedure
Primary	Use of airway interventions	Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation	During procedure
Secondary	The onset of when SpO2 dropped below 80%	The onset of when SpO2 reached below 80%	During procedure
Secondary	The onset of when SpO2 dropped below 70%	The onset of when SpO2 reached below 70%	During procedure
Secondary	The onset of respiratory adverse events	The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation	During procedure
Secondary	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
Secondary	The onset of gastrointestinal adverse events	The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation	During procedure
Secondary	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