Hypoxemia During Surgery
Conditions
Keywords
Nasal cannula, humidified oxygen, hypoxemia, endoscopy
Brief summary
Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation. This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.
Detailed description
This non-blinded, randomized controlled trial compares two study groups, the interventional and control group, to investigate whether HFNO-treatment reduces the risk of hypoxemia during peri-interventional high-risk upper GI endoscopy. The randomization schema is developed by an unblinded statistician using SAS (Statistical system) and uploaded to the REDCap randomization module, enabling delegated team members to generate sequential allocations for enrolled subjects. Patients assigned to the control group will receive supplemental oxygen throughout anesthesia in accordance with hospital guidelines, either using a standard nasal cannula or procedural oxygen mask (POM). The choice of supplemental oxygen delivery, as well as oxygen flow rates, are at the discretion of the anesthesia provider. Post-anesthesia, patients will be transferred to the recovery room with either the standard nasal cannula or procedural oxygen mask at a flow rate determined by the anesthesia provider. Patients assigned to the intervention group will receive humidified oxygen throughout anesthesia in order to assess the effect of HFNO. High-flow nasal cannula (Fisher & Paykel Optiflow) are connected prior to induction of anesthesia, allowing for different flow rates and oxygen concentration to be administered according to the study protocol. The oxygen concentration of the delivered gas for the trial is 100%. Prior to induction, flow rate will be set to 20 liters per minute and increased to 30 liters per minute if tolerated by the patient. After induction of anesthesia, flow rate will be increased to 60 liters per minute and maintained throughout anesthesia. After anesthesia, the high-flow nasal cannula will be exchanged to a standard nasal cannula and the patient will be transferred to the recovery room at which point the flow rate will be determined by the anesthesia provider. The decision to discontinue the intervention of the study is entirely at the discretion of the attending anesthesiologist. Alternative means of supplemental oxygen delivery, such as nasal cannula or oxygen mask, may be considered by the attending anesthesiologist. If the intervention is discontinued, the rationale for the decision is documented for later analysis.
Interventions
DEVICEHFNO-Treatment
The investigated intervention is the application of HFNO throughout a high-risk upper GI-endoscopy. Concentration of oxygen is 100%. Prior to induction, flow rate is set to 20 l/min and increased to 30 l/min if tolerated by the patient. After induction of anesthesia, flow rate is increased to 60 l/min and maintained throughout the anesthesia.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study will be a non-blinded, randomized, controlled trial comparing two study groups (intervention and control). Participants are assigned to one of two groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Upper endoscopy (EGD, ERCP, EUC etc.) w/wo colonoscopy expected duration \> 15 min under MAC * one or more of the following: * Diagnosis of sleep apnea * BMI ≥ 30 kg/m2 * Baseline SpO2 \< 96% or Requirement for long-term oxygen therapy * BOSTN score ≥ 2 * BMI ≥ 30 kg/m2 * Observed apnea * Observed loud Snoring * Daytime Tiredness * Neck circumference ≥ 16.5 inches in female, ≥ 17.5 inches in male
Exclusion criteria
* Known Pregnancy * Known Current infection with COVID-19 * Planned general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Additional actions had to be taken to ensure sufficient SpO2 oxygenation. | The primary outcome will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes | A composite outcome including the occurrence of any airway manipulation due to inadequate ventilation, which may include jaw thrust or Esmarch maneuver, bag-mask ventilation, insertion of a nasogastric tube, laryngeal mask airway or endotracheal intubation or procedural interruption to treat inadequate ventilation. The necessity for airway manipulation is at the discretion of the anesthesia provider. Documentation of the primary outcome is conducted on paper sheets by the anesthesia provider including time, type and reason of upper airway manipulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of care provider | Satisfaction of the provider will be assessed at the end of the procedure upon discharge from the procedure room and will relate to the duration of the procedure, typically between 30 and 120 minutes | Satisfaction of the endoscopist is assessed at the end of the procedure. Satisfaction is rated on a numeric rating scale from 0 to 10, zero being completely dissatisfied and 10 being completely satisfied. |
| Procedure interruption | Procedure interruption will be assessed for the duration of the procedure, which is typically between 30 and 120 minutes | The occurrence of procedure interruption, defined as prompting the endoscopist to stop the procedure, or removal of the scope for treatment of inadequate ventilation. |
| Occurrence of hypoxemia | The occurence of hypexmia will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes | It is determined as SpO2 <92% in the absence of obvious artefacts during anesthesia. Absence of artefacts is defined as the presence of a sinusoid plethysmography curve. |
Countries
United States
Outcome results
None listed