Clinical trial NCT06459167: Position Intervention to Reduce Hypoxemia in Sedation Patients
Official title: Position Intervention to Reduce Hypoxemia in Sedation Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxemia
Sedation Complication
Emergencies
Airway Remodeling
Keywords: position
hypoxemia
sedation
emergency
upper airway
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
name: Shenzhen Second People's Hospital
name: Zhejiang Provincial People's Hospital
name: The Sixth Affiliated Hospital of Wenzhou Medical University
name: Lishui Municipal Central Hospital
name: Ningbo No. 1 Hospital
name: Zunyi Medical College
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2024-06-14
Enrollment: 1752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The lowest SpO2
timeFrame: During procedure
measure: Use of airway interventions
timeFrame: During procedure
Secondary outcomes:
measure: The onset of when SpO2 dropped below 80%
timeFrame: During procedure
measure: The onset of when SpO2 dropped below 70%
timeFrame: During procedure
measure: The onset of respiratory adverse events
timeFrame: During procedure
measure: The onset of circulatory adverse events
timeFrame: During procedure
measure: The onset of gastrointestinal adverse events
timeFrame: During procedure
measure: The degree of operator satisfaction
timeFrame: During procedure
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Xiangming Fang, M.D.
role: PRINCIPAL_INVESTIGATOR
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