Position Intervention to Reduce Hypoxemia in Sedation Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with 18 years or older
Without obvious cardiovascular or pulmonary dysfunction
Scheduled to undergo procedure or surgery with sedation
Signed the informed consent form
Disqualifiers
Preexisting bradycardia (heart rate <50 beats/min), hypotension (systolic blood pressure < 80mmHg), or hypoxemia (SpO2 < 90%);
Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases
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;
Coagulation disorders or a tendency of nose bleeding;
Trial design
Design model
Parallel
Treatments tested in this trial
The position adopted when patients undergoing procedure or surgery
Other interventionFor 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.
Treatment groups
1,752 Participants
are divided into 2 treatment groupsGroup A: Group SExperimental treatment 1 intervention
Group B: Group LExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The lowest SpO2
The lowest SpO2 during sedation and procedures
Time frame
During procedure2
Use of airway interventions
Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation
Time frame
During procedureSecondary outcomes
1
The onset of when SpO2 dropped below 80%
The onset of when SpO2 reached below 80%
Time frame
During procedure2
The onset of when SpO2 dropped below 70%
The onset of when SpO2 reached below 70%
Time frame
During procedure3
The onset of respiratory adverse events
The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation
Time frame
During procedure4
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 procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Zhejiang University
Lead sponsor
Zhejiang Provincial Tongde Hospital
Collaborator
Shenzhen Second People's Hospital
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
The Sixth Affiliated Hospital of Wenzhou Medical University
Collaborator
Lishui Municipal Central Hospital
Collaborator
Ningbo No. 1 Hospital
Collaborator
Zunyi Medical College
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: