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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02429154
Other study ID # 14-204
Secondary ID
Status Completed
Phase N/A
First received March 11, 2015
Last updated January 3, 2018
Start date September 2015
Est. completion date September 30, 2017

Study information

Verified date January 2018
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to show that a permissive hypercapnia during mechanical ventilation in children under general anaesthesia will improve cerebral perfusion.


Description:

Mechanical ventilation interferes with cerebral perfusion via the changes in intrathoracic pressure and/or as a consequence of hypocapnia. This latter occurs frequently following traditional ventilation strategies with relatively high tidal volume and respiratory rate. New trends in anesthesia intend to promote protective lung ventilation by keeping a normocapnic or even mildly hypercapnic state. However, cerebral vascular vasotonicity is carbon dioxide (CO2)-dependent with hypocapnia potentially leading to vasoconstriction and subsequent decrease in cerebral blood flow. Changes in cerebral vasoreactivity can be assessed by the near infrared spectroscopy (NIRS) device. This monitoring evaluates the changes in various parameters (deoxygenated hemoglobin, oxygenated hemoglobin, the tissue oxygenation index (TOI) and the tissue hemoglobin index (THI)) that act as surrogate for cerebral vasoconstriction.

We, therefore designed this prospective observational comparative effectiveness study in order to characterize the potential beneficial effect of permissive hypercapnia on cerebral perfusion in infants.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 30, 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria:

- term neonates during their infancy

- for elective surgery requiring general anesthesia and endotracheal intubation

Exclusion Criteria:

- all infants with cardiac anomalies, chronic pulmonary disease (bronchopulmonary dysplasia, cystic fibrosis, asthma), pulmonary hypertension or cranial hypertension will be excluded

- all infants where no access to the forehead is possible as a consequence of the operating field

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Normocapnia
Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)
Mild Hypercapnia
Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa

Locations

Country Name City State
Switzerland Geneva Children's Hospital Geneva

Sponsors (1)

Lead Sponsor Collaborator
Walid HABRE

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the changes in TOI and THI as measured by NIRS under normocapnia and permissive hypercapnia At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
Secondary Blood gas analysis Assessment changes in oxygen partial pressure (PaO2), carbon dioxide partial pressure (PaCO2) and potential of hydrogen (pH) under one level of ETCO2 5 or 20 minutes after reaching the steady state with ETCO2
Secondary Blood Pressure Non invasive monitoring of blood pressure At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
Secondary Heart rate Non invasive recording of heart rate At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
Secondary Body temperature Naso-pharyngeal temperature probe At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level
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