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The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing Gynecologic Laparoscopic Surgery With Trendelenburg Position

27. september 2012 opdateret af: Tae Soo Hahm, Samsung Medical Center
In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. The investigators tried to evaluate the effect of various inspiratory to expiratory ratio on pulmonary gas exchange by randomized controlled trial.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In patients undergoing gynecologic laparoscopic surgery with trendelenburg position, the disturbance of pulmonary gas exchange frequently occurs due to high intra-abdominal pressure. During the laparoscopic surgery with abdominal gas insufflation, gas exchange disturbance such as CO2 retention, hypoxemia occurs in addition to high plateau airway pressure. The usual strategy against these kinds of problem is pressure-controlled ventilation. However, the gas exchange problem especially CO2 retention can not be solved in some cases. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The efficacy of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. There have been several clinical investigations which applied IRV during general anesthesia. However, there have been debates about the effect of IRV during general anesthesia. Therefore, we tried to apply the IRV for subjects undergoing laparoscopic surgery, and evaluate the effect of different I:E ratio on the pulmonary gas exchange and respiratory mechanics.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-710
        • Samsung Seoul Hospital, Samsung Medical Center

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

20 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients undergoing elective gynecologic laparoscopic surgery
  • the duration of pneumoperitoneum during laparoscopic surgery is more than 40 minutes

Exclusion Criteria:

  • ASA (American society of anesthesiologists) classification of the subjects more than III.
  • Age under 20, or more than 65 years.
  • Past history of pneumothorax, COPD, asthma.
  • Patients with ischemic heart disease, valvular heart disease.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1:2 gruppe
konventionel I:E-forholdsgruppe, indåndingstid: udåndingstid = 1:1
Procedure: conventional I:E ratio
conventional I:E ratio of 1:2 is applied.
Eksperimentel: 1:1 group
1:1 I:E ratio group, inspiratory time : expiratory time = 1:1
Procedure: 1:1 ratio
I:E ratio of 1:1 is applied.
Eksperimentel: 2:1 group
inverse ratio group, inspiratory time : expiratory time = 2:1
Procedure: 2:1 group
Inverse I:E ratio of 2:1 is applied.
Aktiv komparator: 1:2 PEEP group
I:E ratio of 1:2 with external PEEP of 5 cm H2O
Procedure: conventional I:E ratio
conventional I:E ratio of 1:2 is applied.
Procedure: external PEEP
external positive end-expiratory pressure of 5 cmH2O is applied.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
arterielt CO2 partialtryk
Tidsramme: 10 minutter efter induktion af generel anæstesi
arteielt CO2-partialtryk
10 minutter efter induktion af generel anæstesi
arterial CO2 partial pressure
Tidsramme: 30 minutes after start of pneumoperitoneum
arteial CO2 partial pressure
30 minutes after start of pneumoperitoneum
arterial CO2 partial pressure
Tidsramme: 60 minutes after start of pneumoperitoneum
arteial CO2 partial pressure
60 minutes after start of pneumoperitoneum

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
arterial O2 partial pressure
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
arterial O2 partial pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
Mean airway pressure
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Mean airway pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (setting)
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (setting)
10 min after induction, 30 and 60 min after start of pneumoperitoneum
hemodynamic parameters
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
systolic/ diastolic blood pressure, heart rate, mean blood pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
end-tidal CO2 partial pressure
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
end-tidal CO2 partial pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
respiratory compliance
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
Dynamic compliance, Static compliance
10 min after induction, 30 and 60 min after start of pneumoperitoneum
Dead space
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
physiologic dead space / tidal volume (VD/VT)
10 min after induction, 30 and 60 min after start of pneumoperitoneum
work of breathing
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
work of breathing
10 min after induction, 30 and 60 min after start of pneumoperitoneum
peak inspiratory pressure
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
peak inspiratory pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
plateau pressure
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
plateau pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
positive end-expiratory pressure
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
positive end-expiratory pressure
10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (exhaled)
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
tidal volume (exhaled)
10 min after induction, 30 and 60 min after start of pneumoperitoneum
minute ventilation
Tidsramme: 10 min after induction, 30 and 60 min after start of pneumoperitoneum
minute ventilation
10 min after induction, 30 and 60 min after start of pneumoperitoneum

Samarbejdspartnere og efterforskere

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

Sponsor

Samsung Medical Center

Efterforskere

  • Studieleder: Tae Soo Hahm, M.D.,Ph.D., Samsung Medical Center

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

1. juni 2011

Primær færdiggørelse (Faktiske)

1. marts 2012

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

21. juni 2011

Først indsendt, der opfyldte QC-kriterier

22. juni 2011

Først opslået (Skøn)

23. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-04-007

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 .

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