Congenital Diaphragmatic Hernia Clinical Trial
Official title:
the Effect of Different Modes of Mechanical Ventilation on Cerebral Blood Flow During Thoracoscopic Surgeries in Neonates (RCT)
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | November 15, 2020 |
Est. primary completion date | November 8, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Days |
Eligibility |
Inclusion Criteria: - full term neonates - body weight more than 2500 gm Exclusion Criteria: - parents' refusal - preterm neonates - body weight less than 2500 gm - congenital cardiac condition - active chest condition - congenital neurological diseases - abnormal kidney and liver function tests |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
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. — View Citation
Friedman JA, Anderson RE, Meyer FB. Techniques of intraoperative cerebral blood flow measurement. Neurosurg Focus. 2000 Nov 15;9(5):e4. Review. — View Citation
Kirkness CJ. Cerebral blood flow monitoring in clinical practice. AACN Clin Issues. 2005 Oct-Dec;16(4):476-87. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cerebral saturation | 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 | during the whole duration of surgery | |
Secondary | oxygen saturation ( SPO2 ) | recorded before induction of anesthesia then every 15 minutes after induction of anesthesia | during the whole duration of surgery | |
Secondary | arterial partial pressure of carbon dioxide ( PaCO2 ) | recorded before induction of anesthesia then every 30 minutes after induction of anesthesia | during the whole duration of surgery | |
Secondary | End Tidal CO2 ( ETCO2 ) | recorded after induction of anesthesia then every 15 minutes | during the whole duration of surgery | |
Secondary | Positive End Expiratory Pressure ( PEEP ) | any changes in PEEP in case of cerebral desaturation will be recorded | during the whole duration of surgery | |
Secondary | Fraction of inspired oxygen | any changes in FIO2 in case of cerebral desaturation will be recorded | during the whole duration of surgery |
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