Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306950
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit
Sponsor:
Phramongkutklao College of Medicine and Hospital
Organization:
Phramongkutklao College of Medicine and Hospital
Study Overview
Official Title:
Optimization of Cerebral Oximetry And Avoid Cerebral Deoxygenation In Severe Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations more morbidities and a higher mortality rate When using the brain as an index organ interventions to improve brain oxygen delivery may have systemic benefits for these patients
Detailed Description:
We conducted a prospective interventional study Data from all 80 severe traumatic brain injury patients were randomized to either perioperative cerebral regional oxygen saturation rSO2 monitoring with an intervention protocol to prevent cerebral desaturation intervention n 40 or underwent blinded rSO2 monitoring control n 40 Predefined clinical outcomes were assessed by a blinded observer 40 were retrieved on April 1 2021 to February 28 2024 Data collection comprised of patients demographic data treatment process and outcomes of treatment was implemented in the intensive care unit The pre-intervention included all consecutive severe traumatic brain injury patients admitted as participants After ethic approval in all methods and obtaining written informed consent from the legal relatives severe traumatic brain injury patients were enrolled on the basis of inclusion criteria of age 20 years Patients were recruited from the preoperative clinic in cases of neurosurgery with agreement Upon arrival in the emergency department the randomization envelope was opened and patients were assigned into either active treatment intervention or usual care control groups with cerebral oximetry monitoring using NIRS bilaterally Root Prime Medical Corporation MASIMO USA After cleansing the adjacent skin area with alcohol an adhesive optode pad was placed over each frontal to temporal area Resting baseline rSO2 values were obtained after waiting at least 1 minute after the placement of the sensors Once values had stabilized the screen was electronically blinded and the time monitoring and baseline parameters were recorded by taking the data frequency of 1 minute 3 minutes after the start recording For the intervention group an alarm threshold at 55 of the resting baseline rSO2 value was established Continuous rSO2 values were stored on a floppy disk with a 15-second update for the duration of the perioperative period With the application of the scalp dressing and before leaving the ICU monitoring was discontinued and optodes were removed after discharge from the ICU for 10 days
For all severe traumatic brain injury patients the best clinical practices aim at maintaining hemoglobin Hb levels greater than 7 gdl blood glucose within the institutional normal range of 80-180 mgdl and mean arterial pressure MAP of 65 mmHg in the intensive care unit In the intervention group a prioritized management protocol was used to maintain rSO2 values at or above 55 of the baseline threshold With a decrease in rSO2 the patients head position was checked to ensure that it had not been rotated or kinked and the face was observed to detect plethora If PaCO2 or end-tidal CO2 was below 40 mmHg during positive pressure ventilation ventilation was reduced to achieve PaCO2 40 mmHg If MAP was 65 mmHg 40 μg increments of intravenous norepinephrine were administered to achieve an MAP 65 mmHg If the cardiac index was 20 Lm2min administration of dobutamine increased to 25 Lm2min In patients with persistent rSO2 below the treatment threshold FiO2 was increased If Hb was below 7 gdl a red blood cell transfusion was administered immediately Cerebral oximetry monitoring was continued after discharge from the intensive care unit for 10 days To maintain participant blindness no study group identifiers were included with the patient or in the patients charts For neurosurgical intensive care unit postoperatively all patients were transferred to an autonomous protocol-given closed neuro-intensive care unit under the exclusion care of an intensive care unit intensivist without direct reference to the attending neurosurgeons or anesthesiologists Criteria for discharge from the intensive care unit comprised 1 hemodynamic stability defined as absence of vasopressor or inotropic drugs removal of arterial and pulmonary artery or central venous catheters and absence of cardiac arrhythmias 2 post-extubation respiratory parameter adequacy with maintenance of pulse oximetry SpO2 95 with supplemental O2 below 5 Lmin 3 level of consciousness appropriate sufficient to protect their airway and 4 good kidney function urinary output 05 mLkghr Data on ICU admission and discharge times and use of a vasopressor were obtained from the intensive care unit database
The sample size was based upon a projected near infrared spectroscopy NIRS-derived tissue oxygenation published in Annual Intensive Care 2012 about the correlation between near infrared spectroscopy NIRS in anesthesia and intensive care and brain tissue oxygenation and major organ function As a priority assumption we hypothesized that a 50 reduction in the incidence of overall complications would be associated with active NIRS cerebral oximetry Accepting a p-value 005 for statistical significance and a β error of 02 we determined that 40 patients in each group were required for this study The randomization method was done by blinded envelopes assigning treatment allocation and placing them in computer-generated random order which were written in order to sequentially identify each subject that registered in this protocol and was disclosed in the neurosurgical ICU Cerebral deoxygenation means a reduction in saturation below 55 of baseline for 1 minute or longer To minimize the probability of patients reaching these levels interventions to improve cerebral oxygenation were administered when rSO2 decreased to 55 of baseline for 15 s Mean and minimum values of rSO2 Categorical values are presented as numbers percentage and were analyzed using contingency table analysis Fishers exact test χ2 and Wilcoxons rank sum tests as appropriate Continuous variables are presented as mean SD using an unpaired t-test or ANOVA for analysis with a p-value 005 required for statistical significance
80 patients in the ICU were monitored for invasive arterial blood pressure peripheral O2 saturation SpO2 and electrocardiograms Sedative and paralysis agents were given keep the Richmond Agitation Sedation Scale RASS less than -3 and the Bispectral Index BIS 40-60 monitoring based on bedside intensivist judgment including fentanyl propofol midazolam and cisatracurium Patients were mechanically ventilated using a volume-control ventilation mode with a tidal volume of 8 mlkg a respiratory rate adjusted to maintain normocapnia an inspired oxygen fraction adjusted to maintain SpO2 above 95 and an inspiratoryexpiratory ratio of 12 The inclusion criteria were age more than 20 years old Severe traumatic brain injury defined as Glasgow coma scale 8 and the exclusion criteria were patients who had a pregnancy an infection at the forehead a status epilepticus a history of drug addiction and Severe traumatic brain injury combination with metabolic causes
For all severe traumatic brain injury patients the best clinical practices aim at maintaining hemoglobin Hb levels greater than 7 gdl blood glucose within the institutional normal range of 80-180 mgdl and mean arterial pressure MAP of 65 mmHg in the intensive care unit In the intervention group a prioritized management protocol was used to maintain rSO2 values at or above 55 of the baseline threshold With a decrease in rSO2 the patients head position was checked to ensure that it had not been rotated or kinked and the face was observed to detect plethora If PaCO2 or end-tidal CO2 was below 40 mmHg during positive pressure ventilation ventilation was reduced to achieve PaCO2 40 mmHg If MAP was 65 mmHg 40 μg increments of intravenous norepinephrine were administered to achieve an MAP 65 mmHg If the cardiac index was 20 Lm2min administration of dobutamine increased to 25 Lm2min In patients with persistent rSO2 below the treatment threshold FiO2 was increased If Hb was below 7 gdl a red blood cell transfusion was administered immediately Cerebral oximetry monitoring was continued after discharge from the intensive care unit for 10 days To maintain participant blindness no study group identifiers were included with the patient or in the patients charts For neurosurgical intensive care unit postoperatively all patients were transferred to an autonomous protocol-given closed neuro-intensive care unit under the exclusion care of an intensive care unit intensivist without direct reference to the attending neurosurgeons or anesthesiologists Criteria for discharge from the intensive care unit comprised 1 hemodynamic stability defined as absence of vasopressor or inotropic drugs removal of arterial and pulmonary artery or central venous catheters and absence of cardiac arrhythmias 2 post-extubation respiratory parameter adequacy with maintenance of pulse oximetry SpO2 95 with supplemental O2 below 5 Lmin 3 level of consciousness appropriate sufficient to protect their airway and 4 good kidney function urinary output 05 mLkghr Data on ICU admission and discharge times and use of a vasopressor were obtained from the intensive care unit database
The sample size was based upon a projected near infrared spectroscopy NIRS-derived tissue oxygenation published in Annual Intensive Care 2012 about the correlation between near infrared spectroscopy NIRS in anesthesia and intensive care and brain tissue oxygenation and major organ function As a priority assumption we hypothesized that a 50 reduction in the incidence of overall complications would be associated with active NIRS cerebral oximetry Accepting a p-value 005 for statistical significance and a β error of 02 we determined that 40 patients in each group were required for this study The randomization method was done by blinded envelopes assigning treatment allocation and placing them in computer-generated random order which were written in order to sequentially identify each subject that registered in this protocol and was disclosed in the neurosurgical ICU Cerebral deoxygenation means a reduction in saturation below 55 of baseline for 1 minute or longer To minimize the probability of patients reaching these levels interventions to improve cerebral oxygenation were administered when rSO2 decreased to 55 of baseline for 15 s Mean and minimum values of rSO2 Categorical values are presented as numbers percentage and were analyzed using contingency table analysis Fishers exact test χ2 and Wilcoxons rank sum tests as appropriate Continuous variables are presented as mean SD using an unpaired t-test or ANOVA for analysis with a p-value 005 required for statistical significance
80 patients in the ICU were monitored for invasive arterial blood pressure peripheral O2 saturation SpO2 and electrocardiograms Sedative and paralysis agents were given keep the Richmond Agitation Sedation Scale RASS less than -3 and the Bispectral Index BIS 40-60 monitoring based on bedside intensivist judgment including fentanyl propofol midazolam and cisatracurium Patients were mechanically ventilated using a volume-control ventilation mode with a tidal volume of 8 mlkg a respiratory rate adjusted to maintain normocapnia an inspired oxygen fraction adjusted to maintain SpO2 above 95 and an inspiratoryexpiratory ratio of 12 The inclusion criteria were age more than 20 years old Severe traumatic brain injury defined as Glasgow coma scale 8 and the exclusion criteria were patients who had a pregnancy an infection at the forehead a status epilepticus a history of drug addiction and Severe traumatic brain injury combination with metabolic causes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None