Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Preoxygenation With a High-flow Nasal Cannula or a Simple Mask Before General Anesthesia in Head and Neck Surgery

6. maj 2020 opdateret af: Seong-Soo Choi, MD, PhD, Asan Medical Center

Comparison of Preoxygenation With a High-flow Nasal Cannula and a Simple Mask Before Intubation During Induction of General Anesthesia in Patients Undergoing Head and Neck Surgery

Objectives: To assess arterial oxygen partial pressure (PaO2) at defined time points during the preoxygenation and to compare between high flow heated humidified nasal oxygen versus standard preoxygenation with oxygen insufflation via face mask over at least 5 minutes Methods: This randomized, single-blinded, prospective study was conducted at Asan Medical Center in Seoul, Republic of Korea.

Populations: Patients undergoing head and neck surgery Expected outcomes: The course of PaO2 levels is superior to those of the face mask during the whole preoxygenation procedure and after the intubation.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Rationale & background information:

Pre-oxygenation before general anesthesia is usually achieved using oxygen delivered via a facemask before induction of anesthesia; this potentially extends the time available for securing the airway before hypoxemia to 6 min. The lungs are commonly ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged. However, facemask ventilation has traditionally been avoided in the circumstance which has the risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. In addition, if difficult ventilation is anticipated, facemask ventilation may not be possible at all, and 6 minutes with hypoxemia may be insufficient for intubation.

An ideal preoxygenation to extend apnea tolerance during anesthesia induction is essential to avoid live threatening airway incidents. The high-flow nasal cannula, the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand), has the ability to deliver warmed and humidified oxygen through specially designed nasal cannula and enable oxygen to be comfortably delivered at rates of > 70 liter/min. Several study showed that nasal delivery of humidified oxygen to paralyzed and anesthetized patients at these rates maintains oxygenation and achieves acceptable carbon dioxide concentration. The investigators hypothesized that an extended apneic period without facemask ventilation could be particularly beneficial to patients undergoing general anaesthesia.

Study goals and objectives:

To assess arterial oxygen partial pressure (PaO2) at defined time points during the preoxygenation and to compare between high flow heated humidified nasal oxygen versus standard preoxygenation with oxygen insufflation via face mask over at least 5 minutes

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

19 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients with head and neck cancer undergoing resection surgery planned arterial cannulation and invasive arterial blood pressure monitoring and arterial blood gas analysis
  2. Patients over 19-year old
  3. Patients who voluntarily participated in the study
  4. Patents in American Society of Anesthesia physical status 1-3

Exclusion Criteria:

  1. Patients who don't approve to participation
  2. Unable to give informed consent because of a language barrier
  3. Patients with severe respiratory disease
  4. Patients with severe cardiovascular or cerebrovascular disease
  5. Patients with severe psychiatric disorders
  6. Anyone who is not appropriate according to researcher's decision

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group N
pre-oxygenation with High-flow nasal cannula
Apply high flow heated (34 °C) and humidified nasal oxygen with the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand) using a flow of 30 liter/minute and an inspiratory oxygen fraction (FiO2) of 1.0. Increase the oxygen flow to 60 liter/minute over the course of the first minute. Ask the patients not to speak during anesthesia induction and keep the mouth closed.
Aktiv komparator: Group M
pre-oxygenation with simple mask
Perform standard preoxygenation by oxygen insufflation via a face mask using the standard anesthesia ventilators (semicircular system) with 100% oxygen flow of 12 liter/minute. The patients breathe with tidal volume.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PaO2 (arterial oxygen partial pressure) at pre-defined time points.
Tidsramme: through study completion, an average of 10 minutes
changes of PaO2
through study completion, an average of 10 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
degree of blood oxygenation oxygenation
Tidsramme: through study completion, an average of 10 minutes
result of arterial blood gas analysis
through study completion, an average of 10 minutes
various patients' characteristics about airway
Tidsramme: through study completion, an average of 10 minutes
upper lip bite test classification (class 1~3)
through study completion, an average of 10 minutes
degree of difficulty for intubation
Tidsramme: through study completion, an average of 10 minutes
the number of attempts at laryngoscopy and use of any rescue maneuvers, seniority of the anesthesiologist
through study completion, an average of 10 minutes
degree of tissue oxygenation
Tidsramme: through study completion, an average of 10 minutes
O2 saturation
through study completion, an average of 10 minutes

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Seong-Soo Choi, Dr., Department of Anesthesiology and Pain Medicine, Asan Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 (Faktiske)

8. maj 2019

Primær færdiggørelse (Faktiske)

7. april 2020

Studieafslutning (Faktiske)

7. april 2020

Datoer for studieregistrering

Først indsendt

6. marts 2019

Først indsendt, der opfyldte QC-kriterier

28. marts 2019

Først opslået (Faktiske)

1. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019-0275

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med High-flow nasal cannula

Abonner