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 Mannheim
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
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 Mannheim
PD Dr. med. Jörg Krebs
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
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 Mannheim
PD Dr. med. Jörg Krebs
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
Telephone:
0621/383-0
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://umm.de

Principal Investigator

Address:
Universitätsmedizin Mannheim
PD Dr. med. Jörg Krebs
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
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 Mannheim
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
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 Mannheim
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry