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Not yet recruiting NCT07591610

Perioperative High-flow Nasal Oxygen in Patients Undergoing Robotic Surgery

No phase Interventional Robotic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High flow nasal oxygen.
Who it may be relevant to
Registry conditions: Robotic Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • End expiratory lung volume (EELV) [Time frame: 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 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.]
  • Incidence of postoperative pulmonary complications [Time frame: From induction of anesthesia up to postoperative day 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT07591610 · 2026P000304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗