Hypoxemia During Surgery
Conditions
Keywords
HIGH-FLOW OXYGEN, SEDATION, HYPOXEMIA
Brief summary
The study investigates the use of high-flow oxygen therapy devices in patients at higher risk of complications during sedated digestive endoscopies. Sedation controlled by the endoscopist improves patient tolerance and facilitates higher-quality procedures, but it can have side effects such as hypoxemia or respiratory depression, especially in patients with sleep apnea, obesity, lung diseases, those over 60 years old, or with a history of sedation complications. While preventive measures, such as oxygen administration, are taken, the study aims to compare the effectiveness of new high-flow oxygen therapy devices with conventional nasal cannulas to improve safety during endoscopies.
Interventions
DRUGHigh-flow medical oxygen insufflation
High-flow medical oxygen insufflation
DRUGLow-flow medical oxygen insufflation
Low-flow medical oxygen insufflation
Sponsors
Outcomes'10
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be ≥ 18 years old * Sign the Informed Consent * Obesity (BMI ≥ 30 kg/m²) * ASA III * Stable pulmonary disease (no hospitalization in the last 6 months) * Stable heart failure (no hospitalization in the last 6 months) * Diagnosed or suspected obstructive sleep apnea with a score ≥ 3 on the STOP-Bang scale (APPENDIX II) * History of sedation-related complications in a previous ESP.
Exclusion criteria
* ASA IV patients * Worsening heart failure at the time of the endoscopy or unstable (hospitalized \< 6 months) * Worsening respiratory disease at the time of the endoscopy or unstable (hospitalized \< 6 months) * Pregnant women * Use of home oxygen therapy * Patients with orotracheal intubation * Tracheostomized patients * Patients allergic to or unable to use propofol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of episodes of hypoxemia | Periprocedural | The number of hypoxemia episodes per procedure |
| Severity of episode of hypoxemia pO2 value | Periprocedural | Severity of episode of hypoxemia (pO2 90- 80%) - (pO2 \<80%) |
| Duration of episode of hypoxemia (in seconds) | Periprocedural | Duration of episode of hypoxemia (in seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sex (Demographic and explanatory factors) | Periprocedural | Sex (Demographic and explanatory factors) |
| Age (Demographic and explanatory factors) | Periprocedural | Age (Demographic and explanatory factors) |
| Body mass index (Demographic and explanatory factors) | Periprocedural | Body mass index (Demographic and explanatory factors) |
| Demographic and explanatory factors | Periprocedural | anesthetic risk classification: ASA physical status classification Obstructive Sleep Apnea (OSA) or suspected OSA based on the STOP-Bang questionnaire Chronic respiratory disease Chronic heart disease Chronic use of sedative medications History of prior respiratory complication during an endoscopic sedation procedure (ESP) |
| Medical History Demographic and explanatory factors | Periprocedural | Medical History Demographic and explanatory factors |
| Type of Medication and treatment used (Demographic and explanatory factors) | Periprocedural | Type of Medication and treatment used (Demographic and explanatory factors) |
| Variable results | Periprocedural | value of baseline pO2 |
| Length of stay at recovery room and post-procedure (Variable results) | Periprocedural | Length of stay at recovery room and post-procedure |
| pO2 value (Variable results) | Periprocedural | lowest pO2 value during the procedure |
Countries
Spain
Outcome results
None listed