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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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The aim of the study is to assess whether perioperative use of high-flow nasal oxygen (HFNO) during the period from induction of anesthesia until discharge from the post-anesthesia care unit in patients undergoing robotic-assisted surgery reduces perioperative oxygen desaturation and postoperative pulmonary complications.
The investigators hypothesize that perioperative HFNO reduces perioperative oxygen desaturation and reduces postoperative pulmonary complications in patients undergoing robotic-assisted surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | In the control group, patients will receive standard of care anesthesia treatment, consisting of conventional preoxygenation and no active oxygen delivery during the apneic phase of induction. Following extubation, supplemental oxygen will be administered via face mask and subsequently weaned to standard nasal cannula as per routine clinical practice. | |
| Intervention | Experimental | In the intervention group, patients will receive high-flow nasal oxygen starting from induction of anesthesia until intubation, and from extubation until discharge from PACU with weaning of high-flow nasal oxygen during their PACU stay. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal oxygen | Device | In the intervention group, high-flow nasal oxygen (HFNO) will be initiated at the start of preoxygenation and maintained throughout the apneic phase of induction until successful tracheal intubation. HFNO will be reinitiated immediately prior to extubation and continued throughout the early postoperative period until discharge from the post-anesthesia care unit (PACU). HFNO can be discontinued earlier in the PACU at the discretion of the nurse treating the patient, or upon patient request. HFNO can further be changed to standard of care (standard oxygen mask or standard nasal cannula) at any time at the discretion of the anesthesia provider or PACU nurse. Flow rates and fraction of inspired oxygen (FiOâ‚‚) will follow the study protocol (60 liters per minute at 100% O2 for induction of anesthesia, 60 liters per minute at 70% O2 for extubation until 10 minutes after arrival in the PACU with subsequent weaning over the first hour after PACU arrival). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perioperative oxygen desaturation | Incidence of desaturation between induction of anesthesia and discharge from PACU, measured as SpO2 <92% | Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| End expiratory lung volume (EELV) | End expiratory lung volume (EELV), measured as difference between pre-oxygenation to post-induction (5min after intubation) and pre-extubation to post-extubation, and pre-extubation to PACU. EELV will be assessed using electrical impedance tomography. | Assessed at predefined perioperative time points from pre-oxygenation until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arian Karimitar, PhD | Contact | 6176328056 | akarimit@bidmc.harvard.edu | |
| Maximilian S. Schaefer, MD PhD | Contact | msschaef@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| Time-weighted average of oxygen saturation | Time-weighted average of peripherally measured oxygen saturation, during induction of anesthesia (until intubation), between extubation and arrival in the PACU, and during PACU stay. | Assessed continuously from induction of anesthesia until discharge from PACU; duration varies depending on surgical procedure and recovery time, up to 24 hours after surgery. |
| Incidence of postoperative pulmonary complications | Incidence of postoperative pulmonary complications, defined as re-intubation, emergency non-invasive ventilation, pleural effusion or pneumonia | From induction of anesthesia up to postoperative day 3 |