<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04507295</url>
  </required_header>
  <id_info>
    <org_study_id>MS-271-2019</org_study_id>
    <nct_id>NCT04507295</nct_id>
  </id_info>
  <brief_title>Cerebral Blood Flow in Neonates During Thoracoscopic Surgeries</brief_title>
  <official_title>the Effect of Different Modes of Mechanical Ventilation on Cerebral Blood Flow During Thoracoscopic Surgeries in Neonates (RCT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      the aim of this study is to compare the effect of different modes of mechanical ventilation&#xD;
      by using volume-controlled ventilation and pressure-controlled ventilation on cerebral blood&#xD;
      flow monitored by cerebral oximetry during thoracoscopic surgeries in neonates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The brain uses aerobic metabolism exclusively for energy production, so the brain is&#xD;
      critically dependent on the nearly continuous delivery of oxygen to maintain cellular energy&#xD;
      production. Normal cerebral blood flow is approximately 50 ml/100 gram of brain tissue/min.&#xD;
      The brain represents 2% of the total body weight but it receives about 15% of the cardiac&#xD;
      output. The brain is supplied by the circle of Willis which is formed of anastomosis between&#xD;
      the internal carotid artery and the vertebro-basillar system. Monitoring of the CBF depends&#xD;
      on either assessing the blood flow itself (e.g, radioactive substance and transcranial&#xD;
      duplex) or assessing the oxygen delivery to the brain (e.g, cerebral oximetry and jugular&#xD;
      bulb venous O2 saturation). CBF monitoring is an important parameter in both Intensive care&#xD;
      unit and operation room in several aspects e.g, traumatic brain injury (TBI), acute stroke,&#xD;
      carotid artery surgeries and cardiopulmonary bypass.&#xD;
&#xD;
      Cerebral oximetry is a continuous noninvasive technique that monitors the cerebral blood flow&#xD;
      with several advantages over other CBF monitors including the ease of use and interpretation.&#xD;
      It is painless and does not utilize ionizing radiation. The recordings provide real time&#xD;
      information rather than single static measurements. Using the cerebral oximetry has few&#xD;
      limitations including representing local rather than global CBF and absence of normal and&#xD;
      cutoff values.&#xD;
&#xD;
      Thoracoscopic surgery was first introduced in 1910 and allowed a major advance in the field&#xD;
      of thoracic surgery. Then with the improvement of the Instrumentation, thoracoscopic surgery&#xD;
      started in the pediatric field in 1976 for simple procedures and now it is used predominantly&#xD;
      in the pediatric thoracic surgery. The use of thoracoscope has many advantages over the open&#xD;
      approach including using a smaller incision and reducing blood loss, postoperative pain,&#xD;
      hospital stay and musculoskeletal deformities. Thoracoscope utilizes either one lung&#xD;
      ventilation (OLV) or CO2 insufflation technique. In neonates the OLV technique is not&#xD;
      suitable, so CO2 insufflation ( capnothorax ) is usually used.&#xD;
&#xD;
      Several studies were done and revealed the effect of thoracoscopy in neonate on CBF due to&#xD;
      the effect of capnothorax which increases the intrathoracic pressure leading to decreased&#xD;
      venous return and cardiac output, subsequently the CBF decreases, and with the increase of&#xD;
      the insufflation pressure the decease in the CBF becomes more significant. Also the&#xD;
      capnothorax may lead to hypercapnia which leads to changes in the CBF.&#xD;
&#xD;
      The incidence of newborn with congenital anomalies that require surgical procedure during the&#xD;
      neonatal period is not low. With the increase of the survival rate, several studies proved&#xD;
      that exposure of the neonates to surgery and anesthesia is associated with a higher risk of&#xD;
      neuro-developmental delay in different aspects (sensory, motor, language, behavioral,&#xD;
      cognitive, etc.) and thoracoscopic surgery is associated with higher risk due to the nature&#xD;
      of the disease and the surgery. Using cerebral oximetry in addition to other routine monitors&#xD;
      is of added value to maintain CBF within normal range to decrease the incidence of&#xD;
      neurological injuries.&#xD;
&#xD;
      There are few studies showing that using different modes of mechanical ventilation affects&#xD;
      CBF in neonates due to difference in several factors including effect on hemodynamics and&#xD;
      airway pressure but there is no study comparing between volume controlled ventilation and&#xD;
      pressure controlled ventilation. This research gap encourages us to do this study.&#xD;
&#xD;
      Preoperative assessment will be conducted on the patients the day before surgery including&#xD;
      history taking from parents, full examination, routine laboratory investigations; in the form&#xD;
      of CBC, coagulation profile, creatinine, urea, ALT, AST and radiological investigations; in&#xD;
      the form of chest X-ray and echocardiography. the parents (guardians) will be consented to be&#xD;
      included in the study &amp; informed about the required fasting hours.&#xD;
&#xD;
      The patients enrolled in the study will be monitored all through the surgical procedure using&#xD;
      pulse oximeter, non-invasive blood pressure and invasive blood pressure monitor (also for&#xD;
      repeated arterial blood gases sampling), ECG, capnogram in addition to the cerebral oximetry.&#xD;
&#xD;
      Two infant probes of the cerebral oximetry will be applied to the patient on the both sides&#xD;
      of the forehead and the monitor will display the cerebral oxygen saturation from the right&#xD;
      and the left side of the brain digitally and in form of graph then the baseline reading of&#xD;
      the cerebral oxygen saturation will be recorded before induction of anaesthesia.&#xD;
&#xD;
      Induction of general anaesthesia will be performed using a regimen of 1-2 µg/Kg fentanyl IV&#xD;
      and 2-3mg/kg propofol IV then tracheal intubation is facilitated using atracurium 0.5 mg/kg&#xD;
      IV. Ventilation will be mechanically controlled using the routine pressure-controlled mode,&#xD;
      to maintain end tidal CO2 (ETCO2) between 30-35 mmHg.&#xD;
&#xD;
      Anaesthesia will be maintained using 1.6 % isoflurane that will be adjusted according to&#xD;
      hemodynamics changes with top up doses of atracurium as required. After starting of gas&#xD;
      insufflation using pressure of 4-6 mmHg and flow at 0.5 to 1.0 Liter/Minute, ventilation of&#xD;
      patients will be modified according to the protocol of each group.&#xD;
&#xD;
      Recorded data will be analyzed using the statistical package for social sciences, version&#xD;
      20.0 (SPSS Inc., Chicago, Illinois, USA). Quantitative data will be expressed as mean±&#xD;
      standard deviation (SD). Qualitative data will be expressed as frequency and percentage. The&#xD;
      following tests will be done:&#xD;
&#xD;
        -  Independent-samples t-test of significance will be used when comparing between two&#xD;
           means.&#xD;
&#xD;
        -  Mann Whitney U test: for two-group comparisons in non-parametric data.&#xD;
&#xD;
        -  Chi-square (x2) test of significance will be used to compare proportions between&#xD;
           qualitative parameters.&#xD;
&#xD;
        -  The confidence interval is set to 95% and the margin of error accepted is set to 5%. So,&#xD;
           the p-value is considered significant as the following:&#xD;
&#xD;
        -  Probability (P-value) :- P-value &lt;0.05 is considered significant. P-value &lt;0.001 is&#xD;
           considered as highly significant. P-value &gt;0.05 is considered insignificant.&#xD;
&#xD;
      Sample size was calculated using G-power software. The cerebral oxygen saturation in neonates&#xD;
      undergoing thoracoscopic surgery was derived from a previous study and was 73%±7 %.we assumed&#xD;
      that different ventilation mode caused a difference of 10% in cerebral oxygen saturation&#xD;
      .considering a study power of 80% and a p-value of 0.05 to be significant, the sample size&#xD;
      was calculated to be 30 patients (15 in each group)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 8, 2020</start_date>
  <completion_date type="Anticipated">November 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 8, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cerebral saturation</measure>
    <time_frame>during the whole duration of surgery</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation ( SPO2 )</measure>
    <time_frame>during the whole duration of surgery</time_frame>
    <description>recorded before induction of anesthesia then every 15 minutes after induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial partial pressure of carbon dioxide ( PaCO2 )</measure>
    <time_frame>during the whole duration of surgery</time_frame>
    <description>recorded before induction of anesthesia then every 30 minutes after induction of anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End Tidal CO2 ( ETCO2 )</measure>
    <time_frame>during the whole duration of surgery</time_frame>
    <description>recorded after induction of anesthesia then every 15 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive End Expiratory Pressure ( PEEP )</measure>
    <time_frame>during the whole duration of surgery</time_frame>
    <description>any changes in PEEP in case of cerebral desaturation will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of inspired oxygen</measure>
    <time_frame>during the whole duration of surgery</time_frame>
    <description>any changes in FIO2 in case of cerebral desaturation will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Tracheo Esophageal Fistula</condition>
  <condition>Congenital Diaphragmatic Hernia</condition>
  <arm_group>
    <arm_group_label>volume controlled group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 patients in is this group will be ventilated during capnothorax using volume controlled ventilation with the following parameters:&#xD;
FIO2 of 60 %.&#xD;
Tidal Volume (TV) of 6-8 ml/kg.&#xD;
Respiratory rate of 30 breathes/min then the respiratory rate will be modified to maintain the ETCO2 between 30-35 mm Hg.&#xD;
inspiratory to expiratory ratio (I: E) 1:2.&#xD;
using a minimal Positive End Expiratory Pressure (PEEP) of 2 cm H2O.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pressure controlled group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 patients in is this group will be ventilated during capnothorax using pressure controlled ventilation with the following parameters:&#xD;
FIO2 60 %.&#xD;
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.&#xD;
respiratory rate of 30 breathes/min then the respiratory rate will be modified to maintain the ETCO2 between 30-35 mm Hg.&#xD;
I:E ratio of 1:1.5 .&#xD;
Using a minimal PEEP of 2 cm H2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cerebral oximetry ( INVOS 5100 )</intervention_name>
    <description>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&#xD;
Increase FIO2 up to 100%&#xD;
Increase PEEP up to 5 cmH2O&#xD;
Decrease insufflation pressure</description>
    <arm_group_label>pressure controlled group</arm_group_label>
    <arm_group_label>volume controlled group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  full term neonates&#xD;
&#xD;
          -  body weight more than 2500 gm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parents' refusal&#xD;
&#xD;
          -  preterm neonates&#xD;
&#xD;
          -  body weight less than 2500 gm&#xD;
&#xD;
          -  congenital cardiac condition&#xD;
&#xD;
          -  active chest condition&#xD;
&#xD;
          -  congenital neurological diseases&#xD;
&#xD;
          -  abnormal kidney and liver function tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>30 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amel H Abo Elela, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nasr M Abdallah, Assist. Prof</last_name>
    <phone>00201005223734</phone>
    <email>sief.nasr@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ramy N Alkonaiesy, Lecturer</last_name>
    <phone>00201224883990</phone>
    <email>ramyalkonaiesy@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Kirkness CJ. Cerebral blood flow monitoring in clinical practice. AACN Clin Issues. 2005 Oct-Dec;16(4):476-87. doi: 10.1097/00044067-200510000-00005.</citation>
    <PMID>16269893</PMID>
  </reference>
  <reference>
    <citation>Woitzik J, Dreier JP, Hecht N, Fiss I, Sandow N, Major S, Winkler M, Dahlem YA, Manville J, Diepers M, Muench E, Kasuya H, Schmiedek P, Vajkoczy P; COSBID study group. Delayed cerebral ischemia and spreading depolarization in absence of angiographic vasospasm after subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2012 Feb;32(2):203-12. doi: 10.1038/jcbfm.2011.169. Epub 2011 Dec 7.</citation>
    <PMID>22146193</PMID>
  </reference>
  <reference>
    <citation>Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.</citation>
    <PMID>26402848</PMID>
  </reference>
  <reference>
    <citation>Friedman JA, Anderson RE, Meyer FB. Techniques of intraoperative cerebral blood flow measurement. Neurosurg Focus. 2000 Nov 15;9(5):e4. doi: 10.3171/foc.2000.9.5.4.</citation>
    <PMID>16821756</PMID>
  </reference>
  <reference>
    <citation>Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.</citation>
    <PMID>20007987</PMID>
  </reference>
  <reference>
    <citation>Kumar K, Basker S, Jeslin L, Karthikeyan C, Matthias A. Anaesthesia for pediatric video assisted thoracoscopic surgery. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):12-6. No abstract available.</citation>
    <PMID>21804698</PMID>
  </reference>
  <reference>
    <citation>Shah R, Reddy AS, Dhende NP. Video assisted thoracic surgery in children. J Minim Access Surg. 2007 Oct;3(4):161-7. doi: 10.4103/0972-9941.38910.</citation>
    <PMID>19789677</PMID>
  </reference>
  <reference>
    <citation>Dave N, Fernandes S. Anaesthetic implications of paediatric thoracoscopy. J Minim Access Surg. 2005 Mar;1(1):8-14. doi: 10.4103/0972-9941.15240.</citation>
    <PMID>21234138</PMID>
  </reference>
  <reference>
    <citation>Tytgat SH, van Herwaarden MY, Stolwijk LJ, Keunen K, Benders MJ, de Graaff JC, Milstein DM, van der Zee DC, Lemmers PM. Neonatal brain oxygenation during thoracoscopic correction of esophageal atresia. Surg Endosc. 2016 Jul;30(7):2811-7. doi: 10.1007/s00464-015-4559-1. Epub 2015 Oct 21.</citation>
    <PMID>26490769</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hussam Hassan</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>neonates</keyword>
  <keyword>cerebral blood flow</keyword>
  <keyword>cerebral oximetry</keyword>
  <keyword>VATS</keyword>
  <keyword>VCV</keyword>
  <keyword>PCV</keyword>
  <keyword>ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Fistula</mesh_term>
    <mesh_term>Tracheoesophageal Fistula</mesh_term>
    <mesh_term>Hernias, Diaphragmatic, Congenital</mesh_term>
    <mesh_term>Fistula</mesh_term>
    <mesh_term>Hernia, Diaphragmatic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04507295
org study id: MS-271-2019
nct id: NCT04507295
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
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.
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
      IV. 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)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cerebral saturation
time frame: during the whole duration of surgery
description: 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
measure: oxygen saturation ( SPO2 )
time frame: during the whole duration of surgery
description: recorded before induction of anesthesia then every 15 minutes after induction of anesthesia
measure: arterial partial pressure of carbon dioxide ( PaCO2 )
time frame: during the whole duration of surgery
description: recorded before induction of anesthesia then every 30 minutes after induction of anesthesia
measure: End Tidal CO2 ( ETCO2 )
time frame: during the whole duration of surgery
description: recorded after induction of anesthesia then every 15 minutes
measure: Positive End Expiratory Pressure ( PEEP )
time frame: during the whole duration of surgery
description: any changes in PEEP in case of cerebral desaturation will be recorded
measure: Fraction of inspired oxygen
time frame: during the whole duration of surgery
description: any changes in FIO2 in case of cerebral desaturation will be recorded
arm group label: volume controlled group
arm group type: Active Comparator
description: 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.
arm group label: pressure controlled group
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: cerebral oximetry ( INVOS 5100 )
description: 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 group label: pressure controlled group
arm group label: volume controlled group
criteria: 
gender: All
minimum age: 1 Day
maximum age: 30 Days
healthy volunteers: No
last name: Amel H Abo Elela, Prof
role: Principal Investigator
affiliation: Cairo University
last name: Nasr M Abdallah, Assist. Prof
phone: 00201005223734
email: sief.nasr@yahoo.com
last name: Ramy N Alkonaiesy, Lecturer
phone: 00201224883990
email: ramyalkonaiesy@gmail.com
citation: Kirkness CJ. Cerebral blood flow monitoring in clinical practice. AACN Clin Issues. 2005 Oct-Dec;16(4):476-87. doi: 10.1097/00044067-200510000-00005.
PMID: 16269893
citation: Woitzik J, Dreier JP, Hecht N, Fiss I, Sandow N, Major S, Winkler M, Dahlem YA, Manville J, Diepers M, Muench E, Kasuya H, Schmiedek P, Vajkoczy P; COSBID study group. Delayed cerebral ischemia and spreading depolarization in absence of angiographic vasospasm after subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2012 Feb;32(2):203-12. doi: 10.1038/jcbfm.2011.169. Epub 2011 Dec 7.
PMID: 22146193
citation: Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.
PMID: 26402848
citation: Friedman JA, Anderson RE, Meyer FB. Techniques of intraoperative cerebral blood flow measurement. Neurosurg Focus. 2000 Nov 15;9(5):e4. doi: 10.3171/foc.2000.9.5.4.
PMID: 16821756
citation: Murkin JM, Arango M. Near-infrared spectroscopy as an index of brain and tissue oxygenation. Br J Anaesth. 2009 Dec;103 Suppl 1:i3-13. doi: 10.1093/bja/aep299.
PMID: 20007987
citation: Kumar K, Basker S, Jeslin L, Karthikeyan C, Matthias A. Anaesthesia for pediatric video assisted thoracoscopic surgery. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):12-6. No abstract available.
PMID: 21804698
citation: Shah R, Reddy AS, Dhende NP. Video assisted thoracic surgery in children. J Minim Access Surg. 2007 Oct;3(4):161-7. doi: 10.4103/0972-9941.38910.
PMID: 19789677
citation: Dave N, Fernandes S. Anaesthetic implications of paediatric thoracoscopy. J Minim Access Surg. 2005 Mar;1(1):8-14. doi: 10.4103/0972-9941.15240.
PMID: 21234138
citation: Tytgat SH, van Herwaarden MY, Stolwijk LJ, Keunen K, Benders MJ, de Graaff JC, Milstein DM, van der Zee DC, Lemmers PM. Neonatal brain oxygenation during thoracoscopic correction of esophageal atresia. Surg Endosc. 2016 Jul;30(7):2811-7. doi: 10.1007/s00464-015-4559-1. Epub 2015 Oct 21.
PMID: 26490769
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hussam Hassan
investigator title: Doctor
mesh term: Esophageal Fistula
mesh term: Tracheoesophageal Fistula
mesh term: Hernias, Diaphragmatic, Congenital
mesh term: Fistula
mesh term: Hernia, Diaphragmatic