Position Intervention to Reduce Hypoxemia in Sedation Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoxemia Sedation Complication Emergencies Airway Remodeling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group S

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

Group Type EXPERIMENTAL

The position adopted when patients undergoing procedure or surgery

Intervention Type OTHER

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.

Group L

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

Group Type EXPERIMENTAL

The position adopted when patients undergoing procedure or surgery

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No