NCT02429154

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 11, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

March 11, 2015

Last Update Submit

January 3, 2018

Conditions

Hypercapnia

Keywords

spectroscopy, near-infraredInfantAnesthesia, general

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Blood gas analysis

    5 or 20 minutes after reaching the steady state with ETCO2

  • 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

  • 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

  • Body temperature

    At steady state (2-3 minutes) after achieving each level of ETCO2 and every 2 minutes up to 6 minutes for each level

Study Arms (2)

Normocapnia

ACTIVE COMPARATOR

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.

Other: Normocapnia

Mild Hypercapnia

OTHER

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

Other: Mild Hypercapnia

Interventions

NormocapniaOTHER

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

Normocapnia
Mild HypercapniaOTHER

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

Mild Hypercapnia

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • term neonates during their infancy
  • for elective surgery requiring general anesthesia and endotracheal intubation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva Children's Hospital

Geneva, 1206, Switzerland

Location

Related Publications (1)

  • Schopfer L, Habre W, Pichon I, Fodor GH. Effect of Permissive Mild Hypercapnia on Cerebral Vasoreactivity in Infants: A Randomized Controlled Crossover Trial. Anesth Analg. 2021 Oct 1;133(4):976-983. doi: 10.1213/ANE.0000000000005325.

    PMID: 33410612DERIVED

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Walid Habre, MD, PhD

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

March 11, 2015

First Posted

April 29, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 30, 2017

Last Updated

January 4, 2018

Record last verified: 2018-01

Locations

CH(1)