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Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps (ICU)

25. oktober 2019 oppdatert av: Arnaud Bewley, University of California, Davis

Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps: A Randomized Controlled Trial

Patients undergoing free flap reconstructive surgery at University of California, Davis Medical Center (UCDMC) will be assigned randomly into no intervention group (immediate post operative care in an ICU) or intervention group (immediate post operative care in a non-ICU specialty ward). The investigators hypothesize that there is no significant difference in the length of stay (LOS) or complication rate between head and neck free flaps patients managed immediately post-operatively in an ICU versus a non-ICU specialty ward. The primary objective is to compare the postoperative LOS between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward. The secondary objective is to compare differences in the rate of complications between head and neck free flap patients managed initially in an ICU versus a non-ICU specialty ward. Finally, the tertiary objective is to compare differences in resource utilization between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward.

Studieoversikt

Detaljert beskrivelse

Free flaps are an instrumental component of head and neck reconstructive surgery. There is no current consensus on the postoperative management of these patients despite the increasing frequency with which free flaps are used. Although patients often do not have a specific medical indication for postoperative ICU management, they frequently are sent to the ICU for postoperative care based on the need for close nurse monitoring of the flap. In a US based survey in 2007, 88.9% of head and neck surgeons were sending postoperative flap patients to the ICU. Typical ICU length of stay for these patients varies from 2-11 days. There are numerous theoretic disadvantages to ICU care in these patients. ICU care has been associated with increased use of sedation leading to decreased flap perfusion, prolonged use of ventilation, less self care, less ambulation, increased delirium and increased cost.

Due to these concerns, several institutions have developed protocols that allow for the monitoring of head and neck free-flap patients outside of the ICU. Two recent retrospective studies assessed outcomes using these protocols, including 257 patients (119 ICU, 138 ward) and showed no significant difference in morbidity and mortality, or flap failure between the groups. There was a significant increase LOS from 8 to 9 days and transfusion rate, in the ICU group. Another study looked at 247 patients (175 ICU, 72 ward) and found no difference between flap failure, reoperation, hematoma, wound complications between the groups. They also found an increased LOS from 7 to 8 days in the ICU group. They calculated cost difference and found a decrease in average patient cost from $101,199 to $86,195 in the ward group. These studies support the use of non-ICU care for head and neck free-flap patients, however given their retrospective nature significant biases may exist, tempering the strength of their conclusions. To date, there has never been a Randomized Controlled Trial (RCT) that addresses this question.

This is a non-inferiority RCT at UCDMC to assess differences in LOS, complication rate and resource utilization between patients randomized to the ICU and a head and neck specialty ward. Since ICU/Ward bed availability has to be determined before surgery, a subject will be randomized before surgery when the subject meets all inclusion and none of the exclusion criteria. Currently, postoperative flap patients who are not enrolled in the study at UCDMC are monitored in the ICU for a minimum of 24 hours following their surgery.

Studietype

Intervensjonell

Registrering (Faktiske)

112

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • California
      • Sacramento, California, Forente stater, 95817
        • University of California, Davis

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients undergoing free flaps for reconstruction of head and neck surgical defects at UCDMC, including but not limited to, head and neck cancer defects, osteoradionecrosis (ORN), and trauma
  • 18 years of age and older and able to consent

Exclusion Criteria:

  • Vulnerable populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Specialty Ward
Patients who have been randomized into receiving post-operative care at the Non-ICU Specialty ward (intervention) after receiving flap reconstructive surgery on their mucosal or cutaneous defect.
Ingen inngripen: Intensive Care Unit (ICU)
Patients who have been randomized into receiving post-operative care at the intensive care unit after receiving flap reconstructive surgery on their mucosal or cutaneous defect.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of Stay
Tidsramme: 30 days
Number of days
30 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Inpatient Hospital Costs (dollar amounts)
Tidsramme: 30 days
Total inpatient hospital cost, insurance adjustments, and payments
30 days

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post Operative Complication Rate
Tidsramme: 30 days
Flap ischemia, Reopration, Hematoma, wound infection, flap loss, and other complications
30 days
Medical Complications
Tidsramme: 30 days
Pneumonia, thromboembolic event, sepsis, ventilator requirement, cardiovascular complication, poster operative transfusion, delirium, ICU admission, other complications, mortality, readmission status
30 days

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Arnaud Bewley, MD, University of California, Davis

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)

10. april 2016

Primær fullføring (Faktiske)

11. februar 2019

Studiet fullført (Faktiske)

16. april 2019

Datoer for studieregistrering

Først innsendt

8. november 2017

Først innsendt som oppfylte QC-kriteriene

8. november 2017

Først lagt ut (Faktiske)

13. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

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