Cerebral Blood Flow in Neonates During Thoracoscopic Surgeries

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04507295

Collaborator

(none)

Enrollment

Arms

3.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

the aim of this study is to compare the effect of different modes of mechanical ventilation by using volume-controlled ventilation and pressure-controlled ventilation on cerebral blood flow monitored by cerebral oximetry during thoracoscopic surgeries in neonates.

Condition or Disease	Intervention/Treatment	Phase
Tracheo Esophageal Fistula Congenital Diaphragmatic Hernia	Device: cerebral oximetry ( INVOS 5100 )	N/A

Detailed Description

The brain uses aerobic metabolism exclusively for energy production, so the brain is critically dependent on the nearly continuous delivery of oxygen to maintain cellular energy production. Normal cerebral blood flow is approximately 50 ml/100 gram of brain tissue/min. The brain represents 2% of the total body weight but it receives about 15% of the cardiac output. The brain is supplied by the circle of Willis which is formed of anastomosis between the internal carotid artery and the vertebro-basillar system. Monitoring of the CBF depends on either assessing the blood flow itself (e.g, radioactive substance and transcranial duplex) or assessing the oxygen delivery to the brain (e.g, cerebral oximetry and jugular bulb venous O2 saturation). CBF monitoring is an important parameter in both Intensive care unit and operation room in several aspects e.g, traumatic brain injury (TBI), acute stroke, carotid artery surgeries and cardiopulmonary bypass.

Cerebral oximetry is a continuous noninvasive technique that monitors the cerebral blood flow with several advantages over other CBF monitors including the ease of use and interpretation. It is painless and does not utilize ionizing radiation. The recordings provide real time information rather than single static measurements. Using the cerebral oximetry has few limitations including representing local rather than global CBF and absence of normal and cutoff values.

Thoracoscopic surgery was first introduced in 1910 and allowed a major advance in the field of thoracic surgery. Then with the improvement of the Instrumentation, thoracoscopic surgery started in the pediatric field in 1976 for simple procedures and now it is used predominantly in the pediatric thoracic surgery. The use of thoracoscope has many advantages over the open approach including using a smaller incision and reducing blood loss, postoperative pain, hospital stay and musculoskeletal deformities. Thoracoscope utilizes either one lung ventilation (OLV) or CO2 insufflation technique. In neonates the OLV technique is not suitable, so CO2 insufflation ( capnothorax ) is usually used.

Several studies were done and revealed the effect of thoracoscopy in neonate on CBF due to the effect of capnothorax which increases the intrathoracic pressure leading to decreased venous return and cardiac output, subsequently the CBF decreases, and with the increase of the insufflation pressure the decease in the CBF becomes more significant. Also the capnothorax may lead to hypercapnia which leads to changes in the CBF.

The incidence of newborn with congenital anomalies that require surgical procedure during the neonatal period is not low. With the increase of the survival rate, several studies proved that exposure of the neonates to surgery and anesthesia is associated with a higher risk of neuro-developmental delay in different aspects (sensory, motor, language, behavioral, cognitive, etc.) and thoracoscopic surgery is associated with higher risk due to the nature of the disease and the surgery. Using cerebral oximetry in addition to other routine monitors is of added value to maintain CBF within normal range to decrease the incidence of neurological injuries.

There are few studies showing that using different modes of mechanical ventilation affects CBF in neonates due to difference in several factors including effect on hemodynamics and airway pressure but there is no study comparing between volume controlled ventilation and pressure controlled ventilation. This research gap encourages us to do this study.

Preoperative assessment will be conducted on the patients the day before surgery including history taking from parents, full examination, routine laboratory investigations; in the form of CBC, coagulation profile, creatinine, urea, ALT, AST and radiological investigations; in the form of chest X-ray and echocardiography. the parents (guardians) will be consented to be included in the study & informed about the required fasting hours.

The patients enrolled in the study will be monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and invasive blood pressure monitor (also for repeated arterial blood gases sampling), ECG, capnogram in addition to the cerebral oximetry.

Two infant probes of the cerebral oximetry will be applied to the patient on the both sides of the forehead and the monitor will display the cerebral oxygen saturation from the right and the left side of the brain digitally and in form of graph then the baseline reading of the cerebral oxygen saturation will be recorded before induction of anaesthesia.

Induction of general anaesthesia will be performed using a regimen of 1-2 µg/Kg fentanyl IV and 2-3mg/kg propofol IV then tracheal intubation is facilitated using atracurium 0.5 mg/kg

Ventilation will be mechanically controlled using the routine pressure-controlled mode, to maintain end tidal CO2 (ETCO2) between 30-35 mmHg.

Anaesthesia will be maintained using 1.6 % isoflurane that will be adjusted according to hemodynamics changes with top up doses of atracurium as required. After starting of gas insufflation using pressure of 4-6 mmHg and flow at 0.5 to 1.0 Liter/Minute, ventilation of patients will be modified according to the protocol of each group.

Recorded data will be analyzed using the statistical package for social sciences, version 20.0 (SPSS Inc., Chicago, Illinois, USA). Quantitative data will be expressed as mean± standard deviation (SD). Qualitative data will be expressed as frequency and percentage. The following tests will be done:

Independent-samples t-test of significance will be used when comparing between two means.
Mann Whitney U test: for two-group comparisons in non-parametric data.
Chi-square (x2) test of significance will be used to compare proportions between qualitative parameters.
The confidence interval is set to 95% and the margin of error accepted is set to 5%. So, the p-value is considered significant as the following:
Probability (P-value) :- P-value <0.05 is considered significant. P-value <0.001 is considered as highly significant. P-value >0.05 is considered insignificant.

Sample size was calculated using G-power software. The cerebral oxygen saturation in neonates undergoing thoracoscopic surgery was derived from a previous study and was 73%±7 %.we assumed that different ventilation mode caused a difference of 10% in cerebral oxygen saturation .considering a study power of 80% and a p-value of 0.05 to be significant, the sample size was calculated to be 30 patients (15 in each group)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

the Effect of Different Modes of Mechanical Ventilation on Cerebral Blood Flow During Thoracoscopic Surgeries in Neonates (RCT)

Anticipated Study Start Date :

Aug 8, 2020

Anticipated Primary Completion Date :

Nov 8, 2020

Anticipated Study Completion Date :

Nov 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: volume controlled group 15 patients in is this group will be ventilated during capnothorax using volume controlled ventilation with the following parameters: FIO2 of 60 %. Tidal Volume (TV) of 6-8 ml/kg. Respiratory rate of 30 breathes/min then the respiratory rate will be modified to maintain the ETCO2 between 30-35 mm Hg. inspiratory to expiratory ratio (I: E) 1:2. using a minimal Positive End Expiratory Pressure (PEEP) of 2 cm H2O.	Device: cerebral oximetry ( INVOS 5100 ) in case of critical cerebra desaturation occurred which is defined as decrease in cerebral saturation by 20% from the base line the following will be done Increase FIO2 up to 100% Increase PEEP up to 5 cmH2O Decrease insufflation pressure
Active Comparator: pressure controlled group 15 patients in is this group will be ventilated during capnothorax using pressure controlled ventilation with the following parameters: FIO2 60 %. inspiratory pressure adjusted to fulfil the required TV according to the weight of the patient (6-8 ml /kg) then the insufflation pressure will be added to the driving pressure. respiratory rate of 30 breathes/min then the respiratory rate will be modified to maintain the ETCO2 between 30-35 mm Hg. I:E ratio of 1:1.5 . Using a minimal PEEP of 2 cm H2O.	Device: cerebral oximetry ( INVOS 5100 ) in case of critical cerebra desaturation occurred which is defined as decrease in cerebral saturation by 20% from the base line the following will be done Increase FIO2 up to 100% Increase PEEP up to 5 cmH2O Decrease insufflation pressure

Arm

Intervention/Treatment

Active Comparator: volume controlled group

15 patients in is this group will be ventilated during capnothorax using volume controlled ventilation with the following parameters: FIO2 of 60 %. Tidal Volume (TV) of 6-8 ml/kg. Respiratory rate of 30 breathes/min then the respiratory rate will be modified to maintain the ETCO2 between 30-35 mm Hg. inspiratory to expiratory ratio (I: E) 1:2. using a minimal Positive End Expiratory Pressure (PEEP) of 2 cm H2O.

Device: cerebral oximetry ( INVOS 5100 )

in case of critical cerebra desaturation occurred which is defined as decrease in cerebral saturation by 20% from the base line the following will be done Increase FIO2 up to 100% Increase PEEP up to 5 cmH2O Decrease insufflation pressure

Active Comparator: pressure controlled group

15 patients in is this group will be ventilated during capnothorax using pressure controlled ventilation with the following parameters: FIO2 60 %. inspiratory pressure adjusted to fulfil the required TV according to the weight of the patient (6-8 ml /kg) then the insufflation pressure will be added to the driving pressure. respiratory rate of 30 breathes/min then the respiratory rate will be modified to maintain the ETCO2 between 30-35 mm Hg. I:E ratio of 1:1.5 . Using a minimal PEEP of 2 cm H2O.

Device: cerebral oximetry ( INVOS 5100 )

Outcome Measures

Primary Outcome Measures

cerebral saturation [during the whole duration of surgery]
the cerebral oxygen saturation ( % ) will be measured using the cerebral oximetry(INVOS 5100) and will be recorded before induction of anesthesia then every 15 minutes after induction of anesthesia and any attack of cerebral desaturation is recorded

Secondary Outcome Measures

oxygen saturation ( SPO2 ) [during the whole duration of surgery]
recorded before induction of anesthesia then every 15 minutes after induction of anesthesia
arterial partial pressure of carbon dioxide ( PaCO2 ) [during the whole duration of surgery]
recorded before induction of anesthesia then every 30 minutes after induction of anesthesia
End Tidal CO2 ( ETCO2 ) [during the whole duration of surgery]
recorded after induction of anesthesia then every 15 minutes
Positive End Expiratory Pressure ( PEEP ) [during the whole duration of surgery]
any changes in PEEP in case of cerebral desaturation will be recorded
Fraction of inspired oxygen [during the whole duration of surgery]
any changes in FIO2 in case of cerebral desaturation will be recorded