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ONSD Trajectory in Rebound ICH (ONSD/ INH)

19. juli 2026 opdateret af: Mostafa Mohamed, Benha University

Optic Nerve Sheath Diameter Trajectory During Osmotherapy Weaning as a Predictor of Rebound Intracranial Hypertension in Traumatic Brain Injury

The goal of this prospective observational study is to determine whether the trajectory of optic nerve sheath diameter (ONSD) after osmotherapy weaning can predict rebound intracranial hypertension in adult patients with traumatic brain injury requiring osmotherapy for elevated intracranial pressure. The main questions it aims to answer are:

Does the trajectory of ONSD during osmotherapy weaning predict the development of rebound intracranial hypertension? What is the diagnostic accuracy of serial ONSD measurements for the early detection of rebound intracranial hypertension? Researchers will compare patients who develop rebound intracranial hypertension with those who do not to determine whether changes in ONSD trajectory differ significantly between the two groups.

Participants will:

Undergo serial bedside ocular ultrasound examinations for ONSD measurement at predefined time points after osmotherapy weaning.

Receive standard clinical management for traumatic brain injury according to institutional protocols; no additional therapeutic intervention will be administered.

Undergo routine neurological assessments, laboratory investigations, and neuroimaging as clinically indicated.

Be followed for the occurrence of rebound intracranial hypertension and relevant clinical outcomes during their ICU stay

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Traumatic brain injury (TBI) is a major cause of morbidity and mortality worldwide. Cerebral edema and elevated intracranial pressure (ICP) are common secondary complications that require prompt management to prevent further neurological injury. Osmotherapy with hypertonic saline or mannitol is routinely used to reduce ICP; however, withdrawal or weaning of osmotherapy may be associated with rebound intracranial hypertension, which can worsen neurological outcomes if not recognized early.

Optic nerve sheath diameter (ONSD), measured by bedside ocular ultrasonography, is a non-invasive surrogate marker of raised intracranial pressure. Although ONSD has been shown to correlate with ICP in several clinical settings, the predictive value of serial ONSD measurements during osmotherapy weaning for identifying rebound intracranial hypertension has not been adequately investigated.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Mostafa Mohamed Sakr, Critical care MSC
  • Telefonnummer: +201069610038 +201002338765
  • E-mail: sasasakr6@gmail.com

Studiesteder

  • Egypten
    • Qalyobia
      • Banhā, Qalyobia, Egypten
        • Benha university hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients with traumatic brain injury admitted to the intensive care unit who require osmotherapy for cerebral edema management. Eligible patients will undergo serial optic nerve sheath diameter measurements and computed tomography evaluation according to the study protocol.

Beskrivelse

Inclusion Criteria:

  • Adults (≥18 years) with blunt traumatic brain injury admission GCS ≤12
  • (or GCS 13-15 with CT signs of elevated ICP including midline shift ≥5 mm, effaced cisterns, or significant cerebral edema)
  • clinical decision to initiate 20% mannitol osmotherapy

Exclusion Criteria:

  • Ocular conditions precluding ONSD measurement (glaucoma, prior ocular surgery,
  • globe or optic nerve trauma,
  • periorbital edema, orbital masses, optic nerve sheath cysts);
  • planned decompressive surgery or evacuation of mass lesion within 48 hours; limitation of life-sustaining therapy; pregnancy; contraindications to mannitol (baseline sodium >155 mEq/L, osmolality >320 mOsm/kg, eGFR <30 mL/min); penetrating TBI; or concurrent spinal cord injury with shock.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Traumatic Brain Injury Patients Undergoing Osmotherapy Weaning
Adult patients with traumatic brain injury receiving osmotherapy for intracranial hypertension who undergo protocol-defined osmotherapy weaning. Participants will undergo serial optic nerve sheath diameter (ONSD) measurements before and after osmotherapy reduction or discontinuation and will be followed prospectively for the development of rebound intracranial hypertension and related clinical outcomes.
Diagnostisk test: Optic Nerve Sheath Diameter Ultrasonography
Serial ultrasonographic measurement of optic nerve sheath diameter (ONSD) will be performed bilaterally using a standardized transorbital ultrasound technique immediately before osmotherapy reduction or discontinuation (baseline) and at 4, 6, 12, and 24 hours after weaning. Additional measurements may be obtained if clinical deterioration suggestive of rebound intracranial hypertension occurs. ONSD measurements are performed for observational purposes only and will not influence routine clinical management.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Prediction of rebound intracranial hypertension using serial ONSD measurements
Tidsramme: Within 24 hours after osmotherapy reduction or discontinuation
Within 24 hours after osmotherapy reduction or discontinuation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality
Tidsramme: From ICU admission until ICU discharge or death, assessed for up to 28 days.
Death from any cause occurring during the patient's ICU stay following traumatic brain injury and during the study observation period.
From ICU admission until ICU discharge or death, assessed for up to 28 days.
2. Length of ICU Stay:
Tidsramme: From ICU admission until ICU discharge or death, assessed for up to 28 days.
The total duration of ICU admission measured in days from ICU admission until ICU discharge or death.
From ICU admission until ICU discharge or death, assessed for up to 28 days.
Need for rescue ICP therapy:
Tidsramme: Within 48 hours after osmotherapy weaning.
Requirement for additional ICP-lowering interventions beyond restarting osmotherapy due to suspected or confirmed rebound intracranial hypertension. Rescue therapies include: (a) barbiturate infusion (thiopental or pentobarbital), (b) therapeutic hypothermia (target temperature ≤35°C), or (c) controlled hyperventilation (PaCO₂ <30 mmH
Within 48 hours after osmotherapy weaning.
Glasgow Coma Scale trajectory post-weaning
Tidsramme: Measured at baseline (immediately before osmotherapy weaning), then at 4, 6, 12, and 24 hours after weaning (aligned with ONSD measurement time points). The primary analysis will use change in GCS from baseline to 24 hours as a continuous variable.
Neurological status assessed using the Glasgow Coma Scale (GCS). The GCS total score ranges from 3 to 15, with higher scores indicating better neurological function. A decrease of ≥2 points from the baseline GCS score after osmotherapy discontinuation is considered neurological deterioration suggestive of rebound intracranial hypertension.
Measured at baseline (immediately before osmotherapy weaning), then at 4, 6, 12, and 24 hours after weaning (aligned with ONSD measurement time points). The primary analysis will use change in GCS from baseline to 24 hours as a continuous variable.
Time to rebound intracranial hypertension
Tidsramme: Assessed continuously during the first 48 hours after osmotherapy weaning. For patients who do not develop rebound, time will be censored at 48 hours.
The interval (in hours) from complete osmotherapy discontinuation (T0) to the first documented episode of rebound intracranial hypertension. Rebound is identified by either: (a) decline in GCS of ≥2 points from baseline not attributable to other causes, or (b) worsening on brain imaging showing increased cerebral edema or mass effect.
Assessed continuously during the first 48 hours after osmotherapy weaning. For patients who do not develop rebound, time will be censored at 48 hours.

Samarbejdspartnere og efterforskere

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Sponsor

Benha University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

10. juli 2026

Først indsendt, der opfyldte QC-kriterier

19. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MD_6.5.2026

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