Airway Remodeling, Emergencies, Hypoxemia, Sedation Complication
Conditions
Keywords
position, hypoxemia, sedation, emergency, upper airway
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.
Interventions
OTHERThe 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.
Sponsors
Zhejiang Provincial Tongde Hospital
Shenzhen Second People's Hospital
Zhejiang Provincial People's Hospital
The Sixth Affiliated Hospital of Wenzhou Medical University
Lishui Municipal Central Hospital
Ningbo No. 1 Hospital
Zunyi Medical College
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The onset of respiratory adverse events | During procedure | The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to 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 |
| The onset of when SpO2 dropped below 80% | During procedure | The onset of when SpO2 reached below 80% |
| 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 gastrointestinal adverse events | During procedure | The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation |
| The onset of when SpO2 dropped below 70% | During procedure | The onset of when SpO2 reached below 70% |
Countries
China
Contacts
Primary ContactHui Ye, M.D.
Backup ContactXiangming Fang, M.D.
Outcome results
None listed