Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery (Periop HFNO)

Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery: A Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Robotic Surgery
• Intervention / Treatment: Device: High flow nasal oxygen

Detailed Description

The investigators hypothesize that perioperative HFNO reduces perioperative oxygen desaturation and reduces postoperative pulmonary complications in patients undergoing robotic-assisted surgery.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arian Karimitar, PhD; Phone Number: 6176328056; Email: akarimit@bidmc.harvard.edu
• Study Contact Backup: Name: Maximilian S. Schaefer, MD PhD; Email: msschaef@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
      • Contact: Maximilian Schaefer Director, Center for Anesthesia Research Excellence, MD, PhD; Phone Number: +16173063216; Email: msschaef@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >= 18
• Undergoing non-emergent, non-cardiac, intra-abdominal, intra-thoracic or pelvic robot-assisted surgery with an expected duration of at least 2 hours under general anesthesia with planned extubation at the end of the procedure

Exclusion Criteria:

• Known pregnancy
• Preoperative intubation or tracheostomy
• Anatomical or clinical conditions precluding the use of high-flow nasal oxygen (severe midface trauma, recent nasal surgery, severe nasal septum deviation, severe nasal deformation)
• Contraindications to electrical impedance tomography (EIT), including inability to place the EIT belt or presence of active implantable electronic devices (e.g., pacemaker or implantable cardioverter-defibrillator)
• Planned postoperative admission to the intensive care unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Intervention; 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.	Device: High flow nasal oxygen; 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 (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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.
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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Robotic surgery; High-flow nasal oxygenation; Electric Impedance Tomography (EIT); Perioperative oxygenation
• Other Study ID Numbers: 2026P000304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No