Position Intervention to Reduce Hypoxemia in Sedation Patients

N/ANot Yet RecruitingNCT06459167

First Affiliated Hospital of Zhejiang University1,752 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,752

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The lowest SpO2

The lowest SpO2 during sedation and procedures

Time frame: During procedure

Use of airway interventions

Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation

Time frame: During procedure

Secondary Outcomes

The onset of when SpO2 dropped below 80%

The onset of when SpO2 reached below 80%

Time frame: During procedure

The onset of when SpO2 dropped below 70%

The onset of when SpO2 reached below 70%

Time frame: During procedure

The onset of respiratory adverse events

The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation

Time frame: During procedure

The onset of circulatory adverse events

The onset of circulatory adverse events including hypotension, hypertension, bradycardia, tachycardia, new-onset arrhythmia with hemodynamically stable/instability, cardiac arrest, shock

Time frame: During procedure

The onset of gastrointestinal adverse events

The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation

Time frame: During procedure

The degree of operator satisfaction

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.

Time frame: During procedure

Position Intervention to Reduce Hypoxemia in Sedation Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts