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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Abdominal Tissue Oxygenation in Premature Infants Using Near Infrared Spectroscopy

NCT01855347

Infant, Premature, Diseases Hypoxia Necrotizing Enterocolitis

UNKNOWN

NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants

NCT03706976

Neonatal Disorder

COMPLETED NA

Near-infrared Spectroscopy in Cerebral Oxygenation Monitoring in Full Term Neonates

NCT05158881

Cerebral Oxygenation in Full-term Neonates

COMPLETED

Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants

NCT05961670

Respiratory Distress Syndrome, Newborn

UNKNOWN

Influence of IPV on GOR in Infants From 0 to 12 Months.

NCT02124863

Gastro-oesophageal Reflux

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercapnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normocapnia

The Child will be ventilated in order to achieve an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa). Measurements will be performed after steady state condition. Then the ventilation will be reduced to allow ETCO2 to reach 6.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a normocapnia condition.

Group Type ACTIVE_COMPARATOR

Normocapnia

Intervention Type OTHER

Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)

Mild Hypercapnia

The Child will be ventilated in order to achieve a ETCO2 of 6.5 kPa. Measurements will be performed after steady state condition. Then the ventilation will be increased to allow ETCO2 to reach 5.5 kPa before repeating the measurements. Finally, the child will be again ventilated to obtain a mild hypercapnic condition

Group Type OTHER

Mild Hypercapnia

Intervention Type OTHER

Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normocapnia

Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)

Intervention Type OTHER

Mild Hypercapnia

Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No