NCT04507295

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

August 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 5, 2020

Last Update Submit

August 7, 2020

Conditions

Tracheo Esophageal FistulaCongenital Diaphragmatic Hernia

Keywords

neonatescerebral blood flowcerebral oximetryVATSVCVPCVventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • oxygen saturation ( SPO2 )

    during the whole duration of surgery

  • arterial partial pressure of carbon dioxide ( PaCO2 )

    during the whole duration of surgery

  • End Tidal CO2 ( ETCO2 )

    during the whole duration of surgery

  • Positive End Expiratory Pressure ( PEEP )

    during the whole duration of surgery

  • Fraction of inspired oxygen

    during the whole duration of surgery

Study Arms (2)

volume controlled group

ACTIVE COMPARATOR

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 )

pressure controlled group

ACTIVE COMPARATOR

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 )

Interventions

cerebral oximetry ( INVOS 5100 )DEVICE

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 1. Increase FIO2 up to 100% 2. Increase PEEP up to 5 cmH2O 3. Decrease insufflation pressure

pressure controlled groupvolume controlled group

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • full term neonates
  • body weight more than 2500 gm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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: 16269893BACKGROUND

  • 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: 22146193BACKGROUND

  • 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: 26402848BACKGROUND

  • 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: 16821756BACKGROUND

  • 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: 20007987BACKGROUND

  • 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: 21804698BACKGROUND

  • 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: 19789677BACKGROUND

  • 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: 21234138BACKGROUND

  • 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: 26490769BACKGROUND

MeSH Terms

Conditions

Tracheoesophageal FistulaHernias, Diaphragmatic, CongenitalRespiratory Aspiration

Condition Hierarchy (Ancestors)

Esophageal FistulaDigestive System FistulaDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract FistulaRespiratory Tract DiseasesTracheal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaRespiration DisordersPathologic Processes

Study Officials

  • Amel H Abo Elela, Prof

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasr M Abdallah, Assist. Prof

CONTACT

00201005223734sief.nasr@yahoo.com

Ramy N Alkonaiesy, Lecturer

CONTACT

00201224883990ramyalkonaiesy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 11, 2020

Study Start

August 8, 2020

Primary Completion

November 8, 2020

Study Completion

November 15, 2020

Last Updated

August 11, 2020

Record last verified: 2020-08