Position Intervention to Reduce Hypoxemia in Sedation Patients

Zhejiang University

Status: Not yet enrolling

Conditions: Emergencies; Airway Remodeling; Sedation Complication; Hypoxemia

Treatments: Other: The position adopted when patients undergoing procedure or surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06459167

Hypoxemia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,752 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,752 participants in 2 patient groups

Group S

Experimental group

Description:

Patients needing sedation for procedure or surgery are assisted into supine position before they were sedated and kept during the procedure.

Treatment:

Other: The position adopted when patients undergoing procedure or surgery

Group L

Experimental group

Description:

Patients needing sedation for procedure or surgery are assisted into lateral position before they were sedated and kept the procedure.

Treatment:

Other: The position adopted when patients undergoing procedure or surgery