- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03050775
Evaluating Adult Patient Temperatures During Lower Spinal Surgery
3. mai 2018 oppdatert av: Jean M. Guyer, Mayo Clinic
Comparing Patient Temperatures in Adults During Lower Spinal Surgery Using Either a Heated Ventilator Circuit or a Standard Ventilator Circuit With a Heat-Moisture Exchanger
The purpose of this study is to evaluate patients' temperatures after using one of two ventilator circuits (breathing systems): the ANAPOD™ Heat and Humidification System (ANAPOD™ system) or the standard ventilator circuit with a heat-moisture exchanger (standard ventilator).
The ANAPOD™ system will provide additional heat and humidity to patients through their breathing tube while the standard ventilator will not.
The investigators are doing this research study to find out if the ventilator circuit providing additional heat and humidity will keep patients warmer during surgery and after surgery.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients were randomly assigned to either the treatment group or the control group prior to surgery.
Prior to induction, patients in the control group were given inspiratory gas at ambient air temperature (20-22 degrees Celsius) and patients in the treatment group were given inspiratory gas at warmed temperatures (40-41 degrees Celsius).
All patients were induced with general anesthesia in the supine position and repositioned prone following endotracheal intubation and placement of an esophageal stethoscope with a temperature sensor, as per usual hospital practice.
Esophageal temperatures were recorded within 30 minutes of the baseline esophageal temperature and every 10 minutes thereafter for the first hour post-induction.
All patients had a blanket and forced air warming applied to their lower extremities and upper back at 43 degrees Celsius after draping.
All patients had esophageal temperature measurements recorded every 30 minutes until the patient was repositioned supine.
Core temperatures were recorded four hours post-induction for those patients reaching that timeframe.
Studietype
Intervensjonell
Registrering (Faktiske)
70
Fase
- Ikke aktuelt
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
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Elective spine surgery anticipated greater than three hours in duration
- Posterior approach
- An operative site between lumbar one and sacral one
- Involving two or more levels with fusion and/or instrumentation and/or revisions
- American Society of Anesthesiologists (ASA) Status of I-III
Exclusion Criteria:
- Patients with a tracheostomy
- Preoperative temperature >38°C or <36°C on the day of surgery
- Active infection or erythema to the back
- White blood cell count greater than 10,500/microliter (mcL)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Heated Ventilator Circuit
Heated and humidified inspired gases using the ANAPOD™ Heat and Humidification System (Westmed; Tucson, Arizona, USA) circuit prior to induction of general anesthesia in addition to standard ventilation and temperature management.
|
active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
Andre navn:
|
Aktiv komparator: Standard Ventilator Circuit
Standard ventilation and temperature management.
|
no active heat and humidification during anesthesia
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Core Body Temperature
Tidsramme: Approximately four hours post-induction of general anesthesia (or last recorded temperature)
|
Core body temperature will be taken in the esophagus.
The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.
|
Approximately four hours post-induction of general anesthesia (or last recorded temperature)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Intraoperative Core Temperatures Post-induction
Tidsramme: Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
|
Core body temperature will be taken in the esophagus after general anesthesia induction.
|
Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia
|
Number of Subjects With Post-operative Shivering
Tidsramme: Approximately 2 hours after completion of the surgery
|
Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale.
This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe.
Only the highest degree of patient shivering was used in the analysis.
|
Approximately 2 hours after completion of the surgery
|
Hospital Length of Stay
Tidsramme: Surgery to hospital discharge
|
Number of days in the hospital
|
Surgery to hospital discharge
|
Overall Post-operative Temperature
Tidsramme: PACU arrival
|
Temperature at Post Anesthesia Care Unit (PACU) arrival.
|
PACU arrival
|
Number of Participants With Transfusion Within 48 Hours of Surgery
Tidsramme: Within 48 hours of surgery
|
Requirement of blood transfusion within 48 hours of surgery
|
Within 48 hours of surgery
|
Estimated Blood Loss
Tidsramme: duration of surgery
|
The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.
|
duration of surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jean M Guyer, DNP, Mayo Clinic
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)
28. august 2015
Primær fullføring (Faktiske)
5. februar 2017
Studiet fullført (Faktiske)
5. februar 2017
Datoer for studieregistrering
Først innsendt
9. februar 2017
Først innsendt som oppfylte QC-kriteriene
9. februar 2017
Først lagt ut (Faktiske)
13. februar 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15-001604
- UL1TR000135 (U.S. NIH-stipend/kontrakt)
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
Ja
produkt produsert i og eksportert fra USA
Ja
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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