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

1. juni 2026 opdateret af: Maximilian S Schaefer, Beth Israel Deaconess Medical Center

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

190

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
        • Kontakt:
          • Maximilian Schaefer Director, Center for Anesthesia Research Excellence, MD, PhD
          • Telefonnummer: +16173063216
          • E-mail: msschaef@bidmc.harvard.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Enhed: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of perioperative oxygen desaturation
Tidsramme: 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 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
End expiratory lung volume (EELV)
Tidsramme: 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.
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
Tidsramme: 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.
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
Tidsramme: From induction of anesthesia up to postoperative day 3
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beth Israel Deaconess Medical Center

Samarbejdspartnere

Fisher and Paykel Healthcare

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. juli 2029

Studieafslutning (Anslået)

31. oktober 2029

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2026P000304

Plan for individuelle deltagerdata (IPD)

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