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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02829242
Other study ID # NIRS_RALS
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2016
Est. completion date March 25, 2021

Study information

Verified date September 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Some robotic endoscopic surgeries require a steep Trendelenburg position and a carbon dioxide pneumoperitoneum. This minimally invasive approach has the advantages of less postoperative pain, shorter hospital stay and faster recovery. After prolonged operative time in a Trendelenburg position rare but significant complications are a cerebral oedema or a well leg compartment syndrome. Well leg compartment syndrome results from inadequate perfusion in the lower limbs and the perfusion pressure is decreased proportionally to the lower extremity elevation. The condition can lead to release of intracellular proteins and myoglobinuria, hyperpotassaemia and metabolic acidosis followed by cell necrosis. The risk for tissue damage increases after 4 hours in a Trendelenburg position. If not promptly diagnosed and treated, a compartment syndrome has devastating complications like permanent dysfunction, limb loss, renal failure or even death. There are no specific guidelines for diagnosis and for the timing of surgical decompression. Fasciotomy is a clinical decision. There is no universal agreement at which compartment pressure irreversible muscle damage occurs. The only objective diagnostic tool available is currently to measure the intramuscular pressure, however this is invasive, painful and may yield unreliable results. An intracompartment pressure of 0- 10mm Hg is the normal range. Near Infrared Spectroscopy (NIRS) monitors are validated and approved to measure cerebral and somatic tissue oxygenation below the sensors and may help detecting promptly a compartment syndrome. Therefore, the investigators designed the present study to detect a change in the tissue oxygenation in the lower legs during robotic assisted, laparoscopic surgery in the Trendelenburg position.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date March 25, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patients scheduled for robotic assisted laparoscopic surgery in a Trendelenburg position Exclusion Criteria: - Preexisting moderate neurological disease - Moderate cerebrovascular disease - Coronary disease with angina pectoris (CCS = 1) - Peripheral arterial disease II (with intermittent claudicatio) - Cardiac insufficiency (NYHA >2) - Tumour in pharynx, larynx or oesophagus, an aneurysm of the thoracic aorta

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NIRS Monitoring (SenSmart Monitor)


Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position. Change over time in tissue oxygenation in the lower limbs during surgery in the Trendelenburg position. during the operation