The effects of inverse ratio pressure- controlled ventilation on the gas exchange in patients undergoing robot assisted prostatectomy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611000817943
• Date of registration: 04/08/2011
• Prospective Registration: No
• Primary sponsor: jie ae kim
• Public title: The effects of inverse ratio pressure- controlled ventilation on the gas exchange in patients undergoing robot assisted prostatectomy
• Scientific title: The effects of inverse ratio pressure- controlled ventilation on the gas exchange in patients undergoing robot assisted prostatectomy
• Date of first enrolment: 07/06/2011
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12611000817943.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Korea, Republic Of

Contacts

• Name: jie ae kim

• Name: jie ae kim

Key inclusion & exclusion criteria

Inclusion criteria: American Society of Anesthesiologists physical status 1,2 patients undergoing elective robot-assisted prostatectomy
Exclusion criteria: heart failure (defined as New York Heart Association classification more than 3), coronary artery disease, and obstructive pulmonary disease, defined as forced expiratory volume for 1 min below 80%

Age minimum: 45 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

Cancer - Prostate

prostate cancer;robot-assisted prostatectomy;
prostate cancer
robot-assisted prostatectomy

Intervention(s)

Patients will be ventilated with tidal volume 7 ml/kg, inspiratory to expiratory ratio (I:E) of 1:2 in a pressure-controlled mode (PCM)(initial ventilation). After abdominal insufflations of CO2, mechanical ventilation by pressure-controlled mode (PCM) with 5 cmH2O PEEP and I:E of 2:1 will be applied to them during abdominal insufflation of carbon dioxide gas in Trendelenberg position (intervention). The inspiratory pressure will be set to deliver a tidal volume of 7 ml/kg during PCM. After desufflation of abdominal gas, the ventilation will returne to an initial ventilation method of PCM.

Primary Outcome(s)

airway pressures (peak and mean airway pressure and total PEEP) will be measured by continuous expiratory air sampling, using a mainstream sensor (CO2 SMO PLUS 8100, Novametrix Medical System Inc., Wallingford, CT) placed in-line between endotracheal tube and the Y-piece using S/5 monitor (Datex-Engstrom, Helsinki, Finland).[before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal CO2 gas insufflation, and 20 min after return to basal ventilation with abdominal desufflation (Tend)]

Arterial blood gas analysis.[before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal CO2 gas insufflation, and 20 min after return to basal ventilation with abdominal desufflation (Tend)]

lung compliance will be monitored by continuous expiratory air sampling, using a mainstream sensor (CO2 SMO PLUS 8100, Novametrix Medical System Inc., Wallingford, CT) placed in-line between endotracheal tube and the Y-piece using S/5 monitor (Datex-Engstrom, Helsinki, Finland).[before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal CO2 gas insufflation, and 20 min after return to basal ventilation with abdominal desufflation (Tend)]

Secondary Outcome(s)

radial arterial pressure (pulse wave analysis)[before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal insufflation of CO2 gas, and 20 min after return to basal ventilation with abdominal desufflation (Tend)]

heart rate through electrocardiogram[before Trendelenberg position (Tini), every 30 min when receiving a mechanical ventilation with PCM having a different I: E ratio (T30, T60, T90,..) until end of abdominal insufflation of CO2 gas, and 20 min after return to basal ventilation with abdominal desufflation (Tend)]

Secondary ID(s)

nil

Source(s) of Monetary Support

jie ae kim

Ethics review

Status: Approved
Approval date:
Contact:

Samsung Medical Centre Human Research Ethics Committee