Transpulmonary pressure during robot-assisted laparoscopic prostatectomy
Organizational Data
- DRKS-ID:
- DRKS00028559
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-04-27
- Last update in DRKS:
- 2024-02-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
General anesthesia leads to an uneven distribution of the respiratory gas in the lung, especially during laparoscopic procedures (e.g., robot-assisted laparoscopic prostatectomy). This effect is further exacerbated by the head-down positioning required to perform the surgery. The consequences of the uneven distribution of respiratory gas in the lung are collapse of poorly ventilated lung areas (atelectasis) and overdistension of excessively ventilated lung areas (hyperinflation). The described changes increase the risk of perioperative complications affecting the lung and represent an important factor influencing the complication rate after surgical interventions. A possibility to improve the distribution of respiratory gas in the lung is to ventilate with positive pressure remaining in the lung at the end of expiration (PEEP, positive end-expiratory pressure). The positive pressure in the lung at the end of expiration counteracts the pressures acting on the lung from outside, and the difference is called the "transpulmonary pressure". If the transpulmonary pressure is positive, collapse of the lung areas is prevented. The individually optimal positive end-expiratory pressure (PEEP) for each patient, which guarantees a positive transpulmonary pressure and thus prevents collapse of the lung, cannot be determined without individual measurement. The aim of this study is to evaluate the individualized ventilatory setting adapted to the operative conditions in comparison to the routinely used setting. In particular, the effects of an individual PEEP on the patient's respiratory mechanics influenced by the changing operative conditions will be characterized.
Brief summary in scientific language
General anesthesia with mechanical ventilation leads to inhomogeneities in the lung parenchyma with the development of dorsobasal atelectasis and apical hyperinflation due to the necessary muscle relaxation and intubation. Laparoscopic procedures with pneumoperitoneum and especially robot-assisted laparoskopische prostatectomy with additional Trendelenburg positioning lead to aggravation of the described inhomogeneities by increased intra-abdominal pressure, displacement of the diaphragm cranially and influence of the thoracic wall. The resulting alteration of respiratory mechanics with increased airway pressures, end-expiratory airway collapse, and development of atelectasis increases the risk of perioperative pulmonary complications and ventilator-associated lung injury. Intraoperative lung-protective ventilation with low tidal volumes and adequate positive end-expiratory pressure (PEEP) has been identified as an effective measure to reduce perioperative pulmonary complications. Identification of adequate PEEP under the dynamic operative conditions with pneumoperitoneum and Trendelenburg positioning during robotic-assisted laparoscopic prostatectomy requires a comprehensive evaluation of respiratory mechanics. The aim of the present study is to evaluate the ventilation settings individually adapted to the operative conditions in patients during robot-assisted laparoscopic prostatectomy. In particular, the effects of an individual PEEP on the patient's respiratory mechanics altered by changing surgical measures will be characterized.
Health condition or problem studied
- ICD10:
- C61 - Malignant neoplasm of prostate
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Evaluation of PEEP titrated according to end-expiratory transpulmonary pressure in relation to the surgical phase and evaluation of the effects on respiratory mechanics and gas exchange. Data collection by means of respirator and monitor necessary to perform general anesthesia during the planned operation without prolongation of the regular operation time.
Endpoints
- Primary outcome:
- PEEP titrated according to end-expiratory transpulmonary pressure as a function of surgical phase, collected during robot-assisted laparoscopic prostatectomy, measured by an esophageal catheter approved for this purpose, data collected during the planned urologic procedure without additional prolongation of surgical time
- Secondary outcome:
- Selected parameters of respiratory mechanics, gas exchange, and hemodynamics measured during robot-assisted laparoscopic prostatectomy with a suitable respirator and hemodynamics monitor
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Mannheim Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2022-05-01
- Actual study start date:
- 2022-06-27
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-11-07
- Target Sample Size:
- 36
- Final Sample Size:
- 36
Inclusion Criteria
- Sex:
- Male
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Planned robot-assisted laparoscopic prostatectomy at the University Hospital Mannheim, consent for study participation.
Exclusion Criteria
chronic lung diseases, congenital cardiac malformations, high-grade pathologies of the heart valves
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621-383-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://umm.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin MannheimPD Dr. med. Jörg KrebsTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621/383-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://umm.de
Contact for Public Queries
- Address:
- Universitätsmedizin MannheimPD Dr. med. Jörg KrebsTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621/383-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://umm.de
Principal Investigator
- Address:
- Universitätsmedizin MannheimPD Dr. med. Jörg KrebsTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621/383-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://umm.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621/3833233
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://umm.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission II der Universität Heidelberg, Medizinische Fakultät MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.uni-heidelberg.de/forschung/ethikkommission-ii/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-12-18
- Ethics committee number:
- 2021-692
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-02-10
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Participant-related data will only be made available to persons mentioned by name in the ethics application. After evaluation, a publication of the anonymized data is planned.
Study protocol and other study documents
- Study protocols:
- Prüfprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Boesing C, Schaefer L, Schoettler JJ, Quentin A, Beck G, Thiel M, Honeck P, Kowalewski KF, Pelosi P, Rocco PRM, Luecke T, Krebs J. Effects of individualised positive end-expiratory pressure titration on respiratory and haemodynamic parameters during the Trendelenburg position with pneumoperitoneum: A randomised crossover physiologic trial. Eur J Anaesthesiol. 2023 Nov 1;40(11):817-825. doi: 10.1097/EJA.0000000000001894. Epub 2023 Aug 30. PMID: 37649211.
- Date of first publication of study results:
- 2023-11-01
- DRKS entry published for the first time with results:
- 2024-02-07
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry