Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence (POTHeR)

Universidad de Antioquia

Status: Enrolling

Conditions: Mortality; Trendelenburg; Clinical Trials; Prognosis; Recurrence; Chronic Subdural Hematoma

Treatments: Other: Trendelenburg position

Study type: Interventional

Funder types: Other

Identifiers

NCT06911736

102024

Details and patient eligibility

About

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Full description

Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Enrollment: 254 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study

Exclusion criteria

• Pregnant or breastfeeding
• Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,
• History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting
• Simultaneous participation in any other clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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254 participants in 2 patient groups

Control

No Intervention group

Description:

Control group received the usual postoperative care for patients with CSH, which consisted of strict neurological monitoring for at least 24 hours in an inpatient ward or a more complex setting depending on the patient's clinical condition. The head of the patient was positioned neutral (0°), as were the lower limbs, according to institutional care guidelines. The drain (a latex-gloved reservoir or Hemovac drain) was positioned inferior to the head to promote drainage of any subdural debris. Negative pressure was not used except in patients with Hemovac and a subgaleal drain. Typically, after 24 hours of clinical monitoring and symptom improvement, the drain was removed, and the patient was sent home with recommendations and warning signs, if the patient's clinical condition permitted. Postoperative follow-up imaging was not routinely performed as there was no evidence of clinical benefit.

Trendelenburg

Experimental group

Description:

In addition to the management described above, the postoperative position was modified in the intervention group (trendelenburg). After admission to the hospital unit (general ward, special care, or intensive care unit), the patient's position was adjusted with a 30° leg elevation and a 10° downward head tilt. Proper positioning was verified with a goniometer. This position was maintained until the drains were removed, and the patient was then positioned according to usual care. If the patient decided to get out of bed, the nurse occluded the drains and reopened them when the patient returned to the position described for each group.

Treatment:

Other: Trendelenburg position