Clinical trial NCT02829242: Near Infrared Spectroscopy in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position
Official title: Near Infrared Spectroscopy for Determination of Tissue Oxygenation in Patients Undergoing Robotic Assisted Laparoscopic Surgery in the Trendelenburg Position - A Feasibility Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nontraumatic Compartment Syndrome of Leg
Keywords: Near Infrared Spectroscopy
Somatic Saturation
Well Leg Compartment Syndrome
Robotic Assisted Laparoscopic Surgery
Trendelenburg Position
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Department of Surgery

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Tissue oxygenation in the lower limbs during surgery in the Trendelenburg position.
timeFrame: during the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: