The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial
12. marts 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Seoul, Korea, Republikken, 03080
- Seoul National University Hospital
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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 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
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.
|
Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
|
PaCO2 (arterial partial pressure of carbon dioxide)
|
60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PaCO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 5 minutes after anesthesia induction
|
PaCO2 (arterial partial pressure of carbon dioxide)
|
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
|
PaO2 (arterial partial pressure of oxygen)
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5 minutes after anesthesia induction
|
|
PaO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 60 minutes after anesthesia induction
|
PaO2 (arterial partial pressure of oxygen)
|
60 minutes after anesthesia induction
|
|
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
|
|
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)
|
10 min after restoration of supine position
|
|
PaO2 (mmHg) in the patient's arterial blood gas analysis
Tidsramme: 10 min after restoration of supine position
|
PaO2 (arterial partial pressure of oxygen)
|
10 min after restoration of supine position
|
|
Respiratory compliance (Static, Dynamic)
Tidsramme: 5 minutes after anesthesia induction
|
Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
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5 minutes after anesthesia induction
|
|
Respiratory compliance (Static, Dynamic)
Tidsramme: 60 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)
|
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
|
|
oxygen index
Tidsramme: 5 minutes after anesthesia induction
|
oxygen index calculated by PaO2/inspired oxygen fraction
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5 minutes after anesthesia induction
|
|
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
|
|
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
|
|
Alveolar-arterial oxygen difference
Tidsramme: 5 minutes after anesthesia induction
|
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
|
|
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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. november 2016
Primær færdiggørelse (Faktiske)
1. februar 2017
Studieafslutning (Faktiske)
1. april 2017
Datoer for studieregistrering
Først indsendt
13. november 2016
Først indsendt, der opfyldte QC-kriterier
15. november 2016
Først opslået (Skøn)
17. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. marts 2019
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1609-102-793
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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