Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)

Hypercapnia Clinical Trial

— VARO  

Official title:

Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429154
• Other study ID #: 14-204
• 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
• 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

Related Conditions & MeSH terms

• Hypercapnia

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