Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610461
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
High-flow Nasal Oxygen Versus Face Mask or Nasal Cannula for Advanced Endoscopy in High-risk Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None