Selective Antegrade Cerebral Perfusion and Perioperative Optic Nerve Sheath Diameter in Ascending Aortic Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKoşuyolu Kartal Heart Training and Research Hospital

About this trial

In ascending aortic surgery the distal anastomosis may be constructed with the aortic cross-clamp maintained, or, where the extent of the aortic pathology and the geometry of the graft require it, after release of the cross-clamp during a period of systemic circulatory arrest. Both are established surgical approaches. Where the cross-clamp is released, selective antegrade cerebral perfusion (SACP) is an established cerebral protection technique and is applied for that purpose. Where release of the cross-clamp is not required, systemic circulatory arrest is avoided and SACP is not applied. Optic nerve sheath diameter (ONSD) measured by ocular ultrasonography is a non-invasive marker of raised intracranial pressure. Cardiopulmonary bypass may increase blood-brain barrier permeability through hypoperfusion, non-pulsatile flow, hemodilution and systemic inflammation, predisposing to cerebral edema. Perioperative increases in ONSD have been reported after open heart surgery and have been associated with postoperative delirium. Data on how SACP influences perioperative ONSD dynamics in ascending aortic surgery, and whether such changes relate to postoperative delirium, are limited.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Planned or urgent, hemodynamically stable ascending aortic surgery, including supracoronary ascending aortic replacement, aortic root replacement (Bentall procedure) or valve-sparing root surgery (David procedure), limited to cases involving the ascending aortic segment

Perfusion planned through axillary artery cannulation

Written informed consent

Disqualifiers

History of intracranial procedure or intracranial pathology

Previous carotid intervention, or carotid artery stenosis of 50 percent or more on preoperative Doppler ultrasonography

Advanced chronic obstructive pulmonary disease, defined clinically as advanced stage disease with long-term oxygen therapy or a history of frequent exacerbations

Baseline arterial carbon dioxide tension of 55 mmHg or higher on preoperative arterial blood gas analysis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optic nerve sheath and optic nerve diameter ultrasonography

    Diagnostic test

    Ocular ultrasonography with a linear probe of approximately 7-13 MHz, participant supine with the head neutral, eyelids closed, sterile transparent dressing and gel, minimal probe pressure. Optic nerve sheath diameter is measured in the transverse plane 3 mm posterior to the entry of the optic nerve into the globe. Three measurements per eye are averaged, and the mean of the two eyes is recorded. Performed at T0, T1 and T2.

  • Transcranial Doppler ultrasonography

    Diagnostic test

    Transcranial Doppler ultrasonography with a 2 MHz pulsed-wave probe. The M1 segment of the middle cerebral artery is insonated through the temporal window at approximately 45-55 mm depth, bilaterally where a window is obtainable. Three consecutive stable mean flow velocity measurements are taken per side and averaged. Performed at T0, T1 and T2, and where technically feasible during selective antegrade cerebral perfusion and/or circulatory arrest.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Group SACP: cross-clamp release requiredOther 2 interventions
Group B: Group Non-SACP: cross-clamp release not requiredOther 2 interventions

Trial outcomes

Primary outcomes

1

Change in bilateral mean optic nerve sheath diameter (ONSD) over time

Optic nerve sheath diameter in millimetres, measured by ocular ultrasonography 3 mm posterior to the entry of the optic nerve into the globe in the transverse plane. Three measurements are obtained per eye and averaged; the mean of the right and left eye values is the participant value. Higher values indicate a larger sheath diameter and are interpreted as consistent with a higher intracranial pressure. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction term in a linear mixed-effects model with a random intercept for participant.

Time frame
From before anesthesia induction to postoperative hour 24

Secondary outcomes

1

Change in bilateral mean optic nerve diameter (OND) over time

Optic nerve diameter in millimetres, measured at the same level as the sheath diameter between the outer margins of the nerve, excluding the sheath. Three measurements per eye are averaged and the mean of the two eyes is the participant value. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction term in a linear mixed-effects model with a random intercept for participant. Measurements are obtained before anesthesia induction, at the end of surgery after hemodynamic stabilization in the operating room, and at postoperative hour 24 in the intensive care unit.

Time frame
From before anesthesia induction to postoperative hour 24
2

Change in middle cerebral artery mean flow velocity measured by transcranial Doppler

Mean flow velocity in centimetres per second in the M1 segment of the middle cerebral artery, insonated through the temporal window at approximately 45-55 mm depth. Three consecutive stable measurements per side are averaged and the bilateral mean is the participant value. The endpoint is the trajectory across the three time points, evaluated as the group-by-time interaction in a linear mixed-effects model. This analysis is exploratory. Measurements are obtained before anesthesia induction, at the end of surgery after hemodynamic stabilization in the operating room, and at postoperative hour 24 in the intensive care unit.

Time frame
From before anesthesia induction to postoperative hour 24
3

Change in regional cerebral oxygen saturation measured by near-infrared spectroscopy

Bilateral regional cerebral oxygen saturation as a percentage, recorded by near-infrared spectroscopy with adhesive frontal sensors. Baseline value, nadir value, percentage change from baseline, number of desaturation episodes at or beyond a 20 percent relative fall from baseline, and total duration of desaturation in minutes are recorded for each side. Values are recorded before anesthesia induction, before cardiopulmonary bypass, before and after selective antegrade cerebral perfusion, at the end of cardiopulmonary bypass, and at the end of surgery.

Time frame
From before anesthesia induction to the end of surgery
4

Proportion of participants with a positive delirium screen (Nu-DESC >=2)

Delirium screened with the Nursing Delirium Screening Scale, a five-item observational scale scored 0 to 2 per item for a total range of 0 to 10, where higher scores indicate more delirium features. A total score of 2 or more is a positive screen. Screening is performed once the participant is sufficiently awake and communicative; where deep sedation precludes assessment the screen is repeated at an appropriate time and the delay recorded.

Time frame
At postoperative hour 24

Other outcomes

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