Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Beth Israel Deaconess Medical Center
- Study ID
- NCT07591610
- Status
- Not Yet Recruiting
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Conditions
- Robotic Surgery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- High flow nasal oxygen — DEVICEIn 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 (FiO₂) 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).
Study Details
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.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 30, 2029
- Completion
- Oct 31, 2029
Study Design
- Enrollment
- 190 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: ControlIn 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.
- Experimental: InterventionIn 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.
Primary Outcome Measure
Incidence of perioperative oxygen desaturation [ Time Frame: 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 ]
Central Contacts
- Arian Karimitar, PhD6176328056
- Maximilian S. Schaefer, MD PhD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Maximilian Schaefer Director, Center for Anesthesia Research Excellence, MD, PhD +16173063216 |
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