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

6. mai 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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

Studietype

Intervensjonell

Registrering (Faktiske)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Group N
pre-oxygenation with High-flow nasal cannula
Enhet: 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
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Asan Medical Center

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mai 2019

Primær fullføring (Faktiske)

7. april 2020

Studiet fullført (Faktiske)

7. april 2020

Datoer for studieregistrering

Først innsendt

6. mars 2019

Først innsendt som oppfylte QC-kriteriene

28. mars 2019

Først lagt ut (Faktiske)

1. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2019-0275

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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