NCT04687605

Brief Summary

Temporary hypercapnia leads to a reproducible increase of cerebral blood flow (CBF) and brain tissue oxygenation (StiO2) as shown in a previous study (Trial-Identification: NCT01799525). The aim of this study now was to measure the course of carbon dioxide partial pressure (pCO2) reactivity after prolonged hypercapnia, and to evaluate the therapeutic effect of graded hypercapnia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

December 22, 2020

Last Update Submit

December 28, 2020

Conditions

Vasospasm Intracranial

Keywords

SAHHypercapniaDCI

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow (CBF)

    Changes of CBF (absolute, ml/100g tissue/min) under changes of arterial pCO2

    2-4 hours, day 4-14 after SAH

Secondary Outcomes (2)

  • Cerebral tissue oxygen saturation

    2-4 hours, day 4-14 after SAH

  • Glasgow Outcome Score (GOS)

    up to 6 months

Study Arms (1)

Optimum duration of hypercapnia

EXPERIMENTAL

Daily serial measurement of 2 hours under target hypercapnia of pCO2 50 - 55 mmHg by changes of respirator settings once per day

Procedure: Temporary hypercapnia

Interventions

Temporary hypercapniaPROCEDURE

Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH

Optimum duration of hypercapnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aneurysmal SAH
  • Aneurysm occluded by clipping/coiling within 96 hours
  • Hunt/Hess 3-5
  • Fisher 2-4 on initial CT scan
  • Intubated, sedated and mechanically ventilated patient
  • Continous drainage of cerebrospinal fluid (CSF)

You may not qualify if:

  • Age under 18 years
  • Pregnancy
  • Common obstructive lung disease (COLD)
  • potential of hydrogen (pH) in ABG \< 7,25
  • ICP \> 20 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vasospasm, IntracranialHypercapnia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principial Investigator

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 29, 2020

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 29, 2020

Record last verified: 2020-12