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

Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty

21. maj 2026 opdateret af: DanLing Fang, Shanghai 6th People's Hospital

Effect of Intraoperative Forced-air Warming on Perioperative Hypothermia and Related Complications in Patients Undergoing Total Knee Arthroplasty: A Historical Control Study

Perioperative hypothermia is a common complication during total knee arthroplasty (TKA) and may increase the risk of shivering, delayed anesthetic recovery, and postoperative complications. This historical control study aims to evaluate the effectiveness and safety of intraoperative forced-air warming in preventing perioperative hypothermia in patients undergoing primary unilateral TKA.

A total of 240 patients were included. Patients in the historical control group received routine passive warming measures, while patients in the intervention group received additional forced-air warming during the perioperative period. Core body temperature, incidence of inadvertent perioperative hypothermia, anesthetic recovery outcomes, postoperative complications, and safety outcomes were evaluated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This single-center historical control study was conducted at Shanghai 6th People's Hospital between May 2018 and December 2018 to evaluate the effectiveness of intraoperative forced-air warming for preventing perioperative hypothermia in patients undergoing total knee arthroplasty (TKA).

A total of 240 patients undergoing primary unilateral TKA were enrolled and divided into two groups according to the study period. Patients enrolled between May 2018 and August 2018 were assigned to the historical control group and received routine passive warming measures, including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage. Patients enrolled between September 2018 and December 2018 were assigned to the intervention group and received additional active warming using a forced-air warming system during the perioperative period.

The forced-air warming system was initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit (PACU). Core temperature was continuously monitored using a temperature-sensing urinary catheter.

The primary outcomes included perioperative core temperature changes and the incidence of inadvertent perioperative hypothermia, defined as core temperature below 36°C at any perioperative time point. Secondary outcomes included postoperative shivering, emergence agitation, anesthetic recovery time, blood loss, postoperative complications, and safety outcomes including skin burns and surgical site infection.

This study was approved by the Ethics Committee of Shanghai 6th People's Hospital (Approval No. 05.12.19035). Written informed consent was obtained from all participants before enrollment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

240

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200233
        • Shanghai 6th People's Hospital

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 between 60 and 85 years
  • ASA physical status I or II
  • Diagnosed with knee osteoarthritis
  • Undergoing first unilateral primary total knee arthroplasty
  • Able to provide written informed consent

Exclusion Criteria:

  • Abnormal coagulation function (international normalized ratio >1.2)
  • Preoperative body temperature >37.5°C or <36°C
  • Cognitive or psychiatric disorders affecting communication
  • Moderate or severe anemia
  • Body mass index >30 kg/m² or <18.5 kg/m²
  • Moderate or severe malnutrition
  • Surgery duration longer than 4 hours
  • Intraoperative blood loss greater than 500 mL
  • Transfer to surgical intensive care unit after surgery

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Forced-Air Warming Group
Participants received routine passive warming measures plus active warming using a forced-air warming system during the perioperative period.
Enhed: Forced-Air Warming
Active perioperative warming using a forced-air warming system initiated 30 minutes before anesthesia induction and continued until transfer to the post-anesthesia care unit.
Aktiv komparator: Routine Warming Group
Participants received routine passive warming measures including warmed fluids, operating room temperature control, and cotton blanket coverage.
Andet: Routine Passive Warming
Routine perioperative warming measures including warmed intravenous fluids, warmed irrigation fluids, operating room temperature control, and cotton blanket coverage.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Inadvertent Perioperative Hypothermia
Tidsramme: From anesthesia induction to 90 minutes after anesthesia completion
The proportion of participants with core body temperature below 36.0°C at any perioperative time point.
From anesthesia induction to 90 minutes after anesthesia completion
Perioperative Core Temperature Change
Tidsramme: From operating room entry to 90 minutes after anesthesia completion
Core body temperature measured using a temperature-sensing urinary catheter at predefined perioperative time points.
From operating room entry to 90 minutes after anesthesia completion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Shivering
Tidsramme: From the end of surgery to 24 hours postoperatively
Incidence and severity of postoperative shivering assessed using a 0-4 shivering scale.
From the end of surgery to 24 hours postoperatively
Emergence Agitation
Tidsramme: From 30 minutes after surgery to 2 hours postoperatively
Incidence and severity of emergence agitation assessed using the Richmond Agitation-Sedation Scale (RASS, -5 to +4), where higher positive scores indicate greater agitation.
From 30 minutes after surgery to 2 hours postoperatively
Anesthetic Recovery Time
Tidsramme: From the end of anesthesia to 2 hours postoperatively
Recovery outcomes including awakening time, extubation time, and PACU length of stay.
From the end of anesthesia to 2 hours postoperatively
Intraoperative Blood Loss
Tidsramme: During surgery
Estimated blood loss recorded during the surgical procedure.
During surgery
Postoperative Complications
Tidsramme: From the end of surgery to 30 days postoperatively
Incidence of postoperative complications including delirium, nausea and vomiting, cardiac adverse events, skin burns, and surgical site infection.
From the end of surgery to 30 days postoperatively

Samarbejdspartnere og efterforskere

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

Sponsor

Shanghai 6th People's Hospital

Efterforskere

  • Ledende efterforsker: Danling Fang, RN, Shanghai 6th People's Hospital

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)

1. maj 2018

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

31. januar 2019

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • TKA-FAW-2018-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly shared because the study involves retrospective clinical data and institutional privacy restrictions.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 Total knæarthroplastik

Kliniske forsøg med Forced-Air Warming

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Slovenia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner