about HEDOS CLINICAL TRIAL

HEDOS CLINICAL TRIAL is launched to improve patient's safety in thyroid surgery. Due to postoperative continuous pressure monitoring of the cervical compartment pressure, post-thyroidectomy hemorrhage as a potentially life-threatening complication can be detected early in an asymptomatic stage and treated in time before serious complications occur.

post-thyroidectomy hemorrhage

is a rare (~1.8%) but potentially life-threatening complication occuring after thyroid surgery (1). Most of these bleeding events occur in the first 6-12 hours after surgery, but sometimes it occurs later on (2).

The increased cervical compartment pressure can lead to an asphyxia which, if not treated properly, can lead to hypoxic brain damage and death (2). During revision surgery for post-thyroidectomy hemorrhage the rate for serious complications like recurrent laryngeal nerve palsy is elevated (2). Sometimes the suture of the wound needs to be removed at patient's bed-side because of the serious situation and threatening asphyxia, caused by post-thyroidectomy hemorrhage. A situation like this means a major burden for not only the patient but also the treating team (3).

ISAR-M THYRO® hemorrhage detector

Therefore ISAR-M THYRO®, the first available hemorrhage detector on the market, was developed for an early and safe detection of post-thyroidectomy hemorrhage.

It's main function is the postoperative monitoring of the cervical compartment pressure (invasive) using a small probe. Furthermore, it can monitor the neck distension and respiratory frequency (non-invasive).

An automatic alarm is triggered once a continuous pressure elevation above 10mmHg is detected in the cervical compartment. The rescue cascade ending in revision surgery thus can start in an early and asymptomatic stage of this potentially fatal complication of thyroid surgery.

literature:

(1) Maneck M, Dotzenrath C, Dralle H, Fahlenbrach C, Paschke R, Steinmüller T, Tusch E, Jeschke E, Günster C. Komplikationen nach Schilddrüsenoperationen in Deutschland - Eine Routinedatenanalyse von 66.902 AOK Patienten. Chirurg 2017 88:50–57

(2) Lorenz K, Sekulla C, Kern J, Dralle H (2015) Management of postoperative hemorrhage following thyroid surgery. Chirurg 86:17-23

(3) von Ahnen T, von Ahnen M, Militz S, Preußer D, Wirth U, Schardey HM, Schopf S. Compartment Pressure Monitoring After Thyroid Surgery: A Possible Method to Detect a rebleeding. World J Surg. 2017 Apr 25. doi: 10.1007/s00268-017-4020-9