Hypoxia, Gastric Cancer, Gastric Polyp, Colon Polyp, Colon Cancer, Esophageal Cancer
Conditions
Keywords
Capnographic Monitoring, Hypoxia, Gastrointestinal endoscopy, Elderly patients, Propofol
Brief summary
Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.
Interventions
DEVICECapnography monitoring
Standard monitoring and capnographic monitoring.
DEVICEStandard monitoring
Standard monitoring but no capnographic monitoring
Sponsors
Henan Provincial People's Hospital
Qilu Hospital of Shandong University
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* 65 ≤ Age \<80 * patients undergoing gastrointestinal endoscopes * patients signed informed consent form * ASA classification I-II
Exclusion criteria
* Coagulation disorders or a tendency of nose bleeding * An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months * Severe aortic stenosis or mitral stenosis * Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months * Acute myocardial infarction in the last 6 months * Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability * Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy) * Pre-existing bradycardia (heart rate \< 50 / min), or hypoxia (SaO2\< 90 % ) * Need supplemental oxygen because of pre-existing diseases * Emergency procedure or surgery * Multiple trauma * Upper respiratory tract infection * Allergy to propofol or tape and adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxia | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | (75% ≤ SpO2 \< 90% for \<60 s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sub-clinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | (90% ≤ SpO2 \< 95%) |
| The incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | (SpO2 \< 75% or 75% ≤ SpO2 \< 90% for \>/=60 s) |
| The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | capnography curve decreased by half or more than the baseline and even disappeared, SpO2 \>90% |
| The incidence of other adverse events | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force |
Countries
China
Outcome results
None listed