Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia (PRIOR-Trauma)
Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study
Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.
It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.
Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.
Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.
The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Malin Jonsson Fagerlund
- Telefonnummer: 0707691405
- E-post: malin.jonsson-fagerlund@sll.se
Studiesteder
-
-
-
Stockholm, Sverige, SE-17176
- Rekruttering
- Karolinska University Hospital Solna
-
Ta kontakt med:
- Malin Jonsson Fagerlund
- Telefonnummer: +46707691405
- E-post: malin.jonsson.fagerlund@ki.se
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 1 Adult, ≥18 years old
- 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).
Exclusion Criteria:
- 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Tight fitting facemask
Preoxygenation with tight facemask, 100% oxygen.
|
Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
|
|
High flow nasal oxygen
Preoxygenation with high flow nasal oxygen, 100% oxygen
|
Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of patients with a peripheral oxygen saturation (SpO2) below 93%
Tidsramme: From start of anaesthesia until 1 minute after tracheal intubation.
|
Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
|
From start of anaesthesia until 1 minute after tracheal intubation.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lowest median SpO2.
Tidsramme: From start of anaesthesia until 1 minute after tracheal intubation.
|
Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
|
From start of anaesthesia until 1 minute after tracheal intubation.
|
|
End tidal gas levels
Tidsramme: At the first breath after tracheal intubation.
|
Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
|
At the first breath after tracheal intubation.
|
|
Time span from start of preoxygenation until intubation.
Tidsramme: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
|
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
|
Time span from entering trauma room until intubation.
Tidsramme: Could vary depending on patient and trauma, from a couple of minutes up to an hour.
|
Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
|
Could vary depending on patient and trauma, from a couple of minutes up to an hour.
|
|
Difficulties with induction of anaesthesia
Tidsramme: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
|
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
|
Frequency of complications
Tidsramme: Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.
|
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Malin Jonsson Fagerlund, Karolinska University Hospital and Karolinska Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRIOR-Trauma
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .