- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01943227
Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
California
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Sacramento, California, Forenede Stater, 95817
- UC Davis Health System
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- age greater than 18 years
- scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia and positive pressure ventilation using an endotracheal tube
- patient status ASA 1, 2 or 3
- no significant cardio-vascular or respiratory disease
- supine surgical position
Exclusion Criteria:
- Adults unable to give primary consent
- age less than 18 years
- pregnancy
- prisoners
- pre-existing cardiac or pulmonary disease
- infusion of inotropic drugs
- positive end expiratory pressure (PEEP) requirements >8 cm H2O
- increased intra-abdominal pressure (e.g. planned surgical pneumoperitoneum or ascitis)
- intra-operative patient position other than supine
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
6ml/kg
Enthalpy measured in patients receiving controlled positive pressure ventilation 6ml/kg Tidal volume. The VQm monitor samples the gas at a rate of 3 L/min, returning the analyzed gas to the circuit. As the exhaled gas passes through the analytical chamber, the temperature and humidity are measured essentially continuously (40Hz). These data are combined with pressure measurements to determine the exhaled gas volume and then the heat content (enthalpy) is calculated. |
controlled positive pressure ventilation 6ml/kg tidal volume
|
9ml/kg
Enthalpy measured in patients receiving controlled positive pressure ventilation 9ml/kg Tidal volume. The VQm monitor samples the gas at a rate of 3 L/min, returning the analyzed gas to the circuit. As the exhaled gas passes through the analytical chamber, the temperature and humidity are measured essentially continuously (40Hz). These data are combined with pressure measurements to determine the exhaled gas volume and then the heat content (enthalpy) is calculated. |
controlled positive pressure ventilation 9ml/kg tidal volume
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Airway Enthalpy
Tidsramme: 12 months
|
This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy) in Joules per minute.
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Neal Fleming, MD, PhD, Professor, Anesthesiology & Pain Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 483184
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