A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product

NCT04845867 — Unknown, 1470 participants, ISAR-M GmbH

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Thyroid HEmorrhage DetectOr Study

Registry	NCT04845867, acronym HEDOS
Status	Unknown
Study type	Observational
Enrollment	1470 (Estimated)
Sponsor	ISAR-M GmbH (Industry); collaborators: CRI-The Clinical Research Institute GmbH
Conditions	Thyroid
Interventions	ISAR-M THYRO (Device)
Dates	start 2023-10-23, primary completion 2024-10-23 (estimated), completion 2024-11-24 (estimated), first posted 2021-04-15, last updated 2024-07-08
Locations	1 site in Germany

-Summary

After thyroid surgery, 0.6 to 4% of patients develop postoperative bleeding. 90% of this postoperative bleeding occurs within the first 48 hours. Most of the time, the complications are rapidly progressing and require immediate attention. Up to 0.6% of patients with postoperative bleeding die. In a clinical study with postoperative pressure measurements it could be shown that postoperative bleeding without interruption leads to a continuous increase in pressure in the neck, as is observed when coughing and pressing. Systematic invasive pressure measurement in the thyroid compartment after surgery might detect a continuous increase in pressure which is often caused by a growing haematoma, indicating serious post-surgery bleeding at a much earlier time compared to state of the art diagnostic workflow. n routine clinical care, detection of serious haemorrhage depends on the patients alerting symptoms even if post-operative intermittent monitoring of vital parameters and wound conditions is performed according to current medical guidelines and local instructions. Device-based, continuous haemorrhage detection within 36 to 48 hours after surgery would allow to objectively measure an increase in cervical pressure before symptoms occur, i.e. early detection of risk leading to timely therapeutic actions. Thus, the risk of serious complications like hypoxic brain damage and death caused by post-operative haemorrhage is minimized. In addition, the intervention team would be able to fine-tune necessary actions during the rescue procedure based on objective pressure values, e.g. the decision to open cutaneous sutures immediately or later in the operation theatre, and therefore reduce additional perioperative morbidity and increase patients' safety.

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+Arms and interventions

Arm	Type	Interventions	Description
Measurement and digital documentation		Device: ISAR-M THYRO	continuous measurement and digital documentation with alarms and display off

ISAR-M THYRO (Device): A diagnostic device for early detection of haemorrhage following thyroid surgery

+Outcome measures

Primary outcomes

Sensitivity and specificity [within 48 hours following thyroid surgery]: detection of clinically relevant haemorrhage compared to the gold standard of detection in routine clinical care using 15 mmHg as cut-off
Sensitivity and specificity [within 48 hours following thyroid surgery]: Sensitivity and specificity of detection of clinically relevant haemorrhage within 48 hours following thyroid surgery compared to the gold standard of routine clinical care detection in a three-level decision system using 10 and 20 mmHg as cut-offs

Secondary outcomes

Specificity [within 48 hours following thyroid surgery]: Specificity as well as positive and negative predictive values of detection of clinically relevant haemorrhage within 48 hours following thyroid surgery compared to the gold standard of detection in routine clinical care using the two-level and the three-level decision system.following thyroid surgery compared to the gold standard of routine clinical care detection in routine clinical care using the two-level and three-level decision system
Safety of the use of ISAR-M THYRO [1 month]: Safety of the use of ISAR-M THYRO by means of adverse events within 1 month following thyroid surgery

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years.
* Indication for thyroid surgery (e.g. total thyroidectomy, subtotal resection, partial resection or lobectomy) in routine clinical care according to applicable medical guidelines using all adequate surgical approaches.
* Signed informed consent

Exclusion Criteria:

\- Intended use of drains

+Locations (1)

Facility	City	Country	Status
Krankenhaus Agatharied	Hausham	Germany	Recruiting

+Investigators

Markus MA Albertsmeier, Dr., Study chair, Clinic for General, Visceral, Vascular and Transplant Surgery - Großhadern Campus,