Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery

NCT07591610 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026P000304
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Robotic Surgery

Keywords

Electric Impedance Tomography (EIT); High-flow nasal oxygenation; Perioperative oxygenation; Robotic surgery

Outcome Measures

Primary Outcomes (1)

• Perioperative oxygen desaturation

  Occurrence 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 Outcomes (3)

• End expiratory lung volume (EELV)

  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

  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.

• Postoperative pulmonary complications

  From induction of anesthesia up to postoperative day 3

Study Arms (2)

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.

Device: High flow nasal oxygen

Interventions

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 (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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Central Study Contacts

Arian Karimitar, PhD

CONTACT

6176328056; akarimit@bidmc.harvard.edu

Maximilian S. Schaefer, MD PhD

CONTACT

msschaef@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)