Position Intervention to Reduce Hypoxemia in Sedation Patients

Not Applicable

Not yet recruiting

• Conditions: Hypoxemia; Sedation Complication; Airway Remodeling; Emergencies
• Interventions: Other: The position adopted when patients undergoing procedure or surgery

• Registration Number: NCT06459167
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

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 Timeline

• Study First Submitted: 2024-05-24
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Study Start: 2024-06-20
• Primary Completion: 2026-05-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1752

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	The position adopted when patients undergoing procedure or surgery	Patients needing sedation for procedure or surgery are assisted into supine position before they were sedated and kept during the procedure.
Group L	The position adopted when patients undergoing procedure or surgery	Patients needing sedation for procedure or surgery are assisted into lateral position before they were sedated and kept the procedure.

Primary Outcome Measures

Name	Time	Method
The lowest SpO2	During procedure	The lowest SpO2 during sedation and procedures
Use of airway interventions	During procedure	Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
The onset of respiratory adverse events	During procedure	The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation
The degree of operator satisfaction	During procedure	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.
The onset of when SpO2 dropped below 80%	During procedure	The onset of when SpO2 reached below 80%
The onset of when SpO2 dropped below 70%	During procedure	The onset of when SpO2 reached below 70%
The onset of gastrointestinal adverse events	During procedure	The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation
The onset of circulatory adverse events	During procedure	The onset of circulatory adverse events including hypotension, hypertension, bradycardia, tachycardia, new-onset arrhythmia with hemodynamically stable/instability, cardiac arrest, shock

Trial Locations

Locations (1)

The First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China