High-Flow Nasal Oxygen for Robotic Surgery

(Periop HFNO Trial)

AK
MS
Overseen ByMaximilian S. Schaefer, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether high-flow nasal oxygen (a special method of delivering oxygen) during robotic-assisted surgery can reduce breathing problems during and after the procedure. It aims to prevent low oxygen levels and lung issues in patients undergoing specific surgeries, such as those in the abdomen or chest, lasting at least two hours. Suitable candidates for this trial are adults undergoing these surgeries who will not require intensive care afterward. As an unphased trial, it provides patients the chance to contribute to significant research that could enhance surgical outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that high-flow nasal oxygen is safe for use during robotic surgery?

Research has shown that high-flow nasal oxygen (HFNO) is generally safe during surgery. Studies have found that it can improve oxygen levels and ease breathing. For instance, one study discovered that HFNO allowed patients to maintain higher oxygen levels and experience fewer breathing problems during surgery compared to traditional methods.

Another study found that HFNO is very safe and might assist with breathing after surgery. However, rare cases of airway fires have occurred when HFNO is used with certain surgical tools, such as lasers, so caution is advised. Overall, HFNO has a good safety record and is well-tolerated by patients.12345

Why are researchers excited about this trial?

Researchers are excited about high-flow nasal oxygen for robotic surgery because it offers a new way to maintain oxygen levels during anesthesia. Unlike the standard approach, which involves conventional preoxygenation and does not provide active oxygen during the apneic phase, high-flow nasal oxygen delivers a continuous stream of oxygen. This could lead to better oxygenation during critical periods, like induction and recovery, potentially improving patient outcomes and safety. Additionally, it may offer a more comfortable experience for patients compared to face masks or standard nasal cannulas.

What evidence suggests that high-flow nasal oxygen is effective for reducing perioperative oxygen desaturation and postoperative pulmonary complications?

This trial will compare high-flow nasal oxygen (HFNO) with standard care during robotic surgery. Studies have shown that HFNO can be very effective during surgery. Research indicates that HFNO improves oxygen levels in patients more effectively than traditional face masks. It significantly increases blood oxygen levels, easing patients' breathing. Evidence also suggests that HFNO reduces the risk of low oxygen levels after surgery, which is crucial for recovery. Additionally, it helps maintain stable oxygen levels even when breathing temporarily stops during surgery. This treatment offers a promising way to enhance patient safety during robotic surgeries.24678

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have robotic-assisted surgery under general anesthesia. People with certain medical conditions or factors that could interfere with the study may not be able to participate.

Inclusion Criteria

I am 18 years old or older.
I am having a planned robot-assisted abdominal, chest, or pelvic surgery lasting 2+ hours.

Exclusion Criteria

Known pregnancy
I had a breathing tube or tracheostomy before surgery.
I am scheduled to stay in the ICU after my surgery.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Perioperative Treatment

Participants receive high-flow nasal oxygen from induction of anesthesia until discharge from PACU

Up to 24 hours
Continuous monitoring during surgery and PACU stay

Postoperative Follow-up

Participants are monitored for postoperative pulmonary complications

3 days

What Are the Treatments Tested in This Trial?

Interventions

  • High-flow Nasal Oxygen

Trial Overview

The study is testing if using high-flow nasal oxygen during and after robotic surgery can lower the risk of low blood oxygen levels and lung problems compared to standard care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Fisher and Paykel Healthcare

Industry Sponsor

Trials
127
Recruited
11,000+
Dr. Justin Vaughan profile image

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon profile image

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Citations

Perioperative High-flow Nasal Oxygen in Patients Undergoing ...

The aim of the study is to assess whether perioperative use of high-flow nasal oxygen (HFNO) during the period from induction of anesthesia ...

Application of high-flow nasal oxygen during anesthesia ...

Primary outcome. For the primary endpoint of lowest SpO2 during anesthesia induction, HFNO was non-inferior to facemask ventilation. The median ...

High-Flow Nasal Oxygen Therapy in Preventing Post ... - PMC

Objectives: To evaluate the effectiveness of HFNOT compared to COT in reducing post-extubation hypoxaemia and PPCs in adult surgical patients, ...

Comparison of the effectiveness of high-flow nasal oxygen ...

We found the PaO2 was higher in HFNO group than FMV group with a MD (95% CI) of 57.38 mmHg (25.65 to 89.10; p = 0.0004) after preoxygenation and ...

Perioperative High-flow Nasal Oxygen in Patients ...

The aim of the study is to assess whether perioperative use of high-flow nasal oxygen (HFNO) during the period from induction of anesthesia ...

Oxygen treatment using high flow nasal oxygen after major ...

Breathing after surgery may be temporarily better if taking part in the study and receive HFNO, but this isn't known for certain. The treatment is very safe and ...

Randomized Controlled Trial Investigating the Impact of High ...

In this study, we aimed to investigate the impact of HFNC on postoperative atelectasis in individuals undergoing robotic-assisted laparoscopic surgery.

Safe Use of High-Flow Nasal Oxygen (HFNO) With Special ...

The benefits of HFNO in this setting include improved oxygenation (even with prolonged apnea), decreased work of breathing, and even some CO2 ...