The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
12. mars 2019 oppdatert av: Won Ho Kim, MD, Seoul National University Hospital
Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy.
Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur.
Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome.
The investigators attempt to test the hypothesis that prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic surgery.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy.
Due to increased intrathoracic pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur.
Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome.
The investigators attempt to test the hypothesis that prolonged inspiratory time (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic surgery.
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Seoul, Korea, Republikken, 03080
- Seoul National University Hospital
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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
20 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists physical status class I-II and scheduled for an elective robot-assisted laparoscopic radical prostatectomy or robot-assisted laparoscopic radical cystectomy
- Patients who voluntarily decides to participate in the trial and has agreed in written informed consent
Exclusion Criteria:
- Patients with the anatomical abnormalities of respiratory system(abnormal airway anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity ( Body Mass Index [BMI] > 30kg/m2), severe hepatic failure or renal failure
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 1:2, 1:1 group
Inspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy.
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Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
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Aktiv komparator: 1:1, 1:2 group
Inspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy.
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Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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PaCO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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PaCO2 (arterial partial pressure of carbon dioxide)
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60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 5 minutes after anesthesia induction
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PaCO2 (arterial partial pressure of carbon dioxide)
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5 minutes after anesthesia induction
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PaO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 5 minutes after anesthesia induction
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PaO2 (arterial partial pressure of oxygen)
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5 minutes after anesthesia induction
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PaO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 60 minutes after anesthesia induction
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PaO2 (arterial partial pressure of oxygen)
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60 minutes after anesthesia induction
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PaCO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 120 minutes after anesthesia induction
|
PaCO2 (arterial partial pressure of carbon dioxide)
|
120 minutes after anesthesia induction
|
|
PaO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
PaO2 (arterial partial pressure of oxygen)
|
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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PaCO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 10 min after restoration of supine position
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PaCO2 (arterial partial pressure of carbon dioxide)
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10 min after restoration of supine position
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PaO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 10 min after restoration of supine position
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PaO2 (arterial partial pressure of oxygen)
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10 min after restoration of supine position
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Respiratory compliance (Static, Dynamic)
Tidsramme: 5 minutes after anesthesia induction
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Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
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5 minutes after anesthesia induction
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Respiratory compliance (Static, Dynamic)
Tidsramme: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
|
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
|
Respiratory compliance (Static, Dynamic)
Tidsramme: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
|
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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oxygen index
Tidsramme: 5 minutes after anesthesia induction
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oxygen index calculated by PaO2/inspired oxygen fraction
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5 minutes after anesthesia induction
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oxygen index
Tidsramme: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
oxygen index calculated by PaO2/inspired oxygen fraction
|
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
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oxygen index
Tidsramme: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
oxygen index calculated by PaO2/inspired oxygen fraction
|
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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Alveolar-arterial oxygen difference
Tidsramme: 5 minutes after anesthesia induction
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5 minutes after anesthesia induction
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Alveolar-arterial oxygen difference
Tidsramme: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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Alveolar-arterial oxygen difference
Tidsramme: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.
- Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.
- De Carlo F, Celestino F, Verri C, Masedu F, Liberati E, Di Stasi SM. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: surgical, oncological, and functional outcomes: a systematic review. Urol Int. 2014;93(4):373-83. doi: 10.1159/000366008. Epub 2014 Sep 23.
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)
1. november 2016
Primær fullføring (Faktiske)
1. februar 2017
Studiet fullført (Faktiske)
1. april 2017
Datoer for studieregistrering
Først innsendt
13. november 2016
Først innsendt som oppfylte QC-kriteriene
15. november 2016
Først lagt ut (Anslag)
17. november 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mars 2019
Sist bekreftet
1. september 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1609-102-793
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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