Position Intervention to Reduce Hypoxemia in Sedation Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emergencies; Airway Remodeling; Hypoxemia; Sedation Complication
• Intervention / Treatment: Other: The position adopted when patients undergoing procedure or surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1752
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Ye, M.D.; Phone Number: 8615267048716; Email: yehui@zju.edu.cn
• Study Contact Backup: Name: Xiangming Fang, M.D.; Phone Number: 8613857161019; Email: xmfang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; 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; 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.
Experimental: Group L; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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%	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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: The First Affiliated Hospital of Zhengzhou University; Shenzhen Second People's Hospital; Zhejiang Provincial People's Hospital; Ningbo No. 1 Hospital; Zunyi Medical College; Zhejiang Provincial Tongde Hospital; The Sixth Affiliated Hospital of Wenzhou Medical University; Lishui Municipal Central Hospital
• Investigators: Principal Investigator: Xiangming Fang, M.D., Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: emergency; sedation; position; hypoxemia; upper airway
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Emergencies; Hypoxia; Airway Remodeling
• Other Study ID Numbers: Hypoxemia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No