Respiratory system mechanics and electrical impedance tomography measurements during mechanical ventilation with heliox in infants with respiratory syncytial virus lower respiratory tract disease

ISRCTN ISRCTN98152468
DOI https://doi.org/10.1186/ISRCTN98152468
Secondary identifying numbers NL198 (NTR235)
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
26/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M C J Kneyber
Scientific

VU Medical Centre
Office 8 D 11
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 444 2413
Email m.kneyber@vumc.nl

Study information

Study designRandomised, active controlled, crossover group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleRespiratory system mechanics and electrical impedance tomography measurements during mechanical ventilation with heliox in infants with respiratory syncytial virus lower respiratory tract disease
Study objectives1. First, mechanical ventilation with a gas mixture composed of helium and oxygen is only beneficial in patients with obstructive Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV LRTD). Hence correct identification of the clinical phenotype is necessitated. This can be done with lung function testing, including compliance and resistance.
2. Second, the beneficial effect of heliox can be detected with repeated Electrical Impedance Tomography (EIT) measurements.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedRespiratory Syncytial Virus Lower Respiratory Tract Disease (RSV LRTD)
InterventionMechanical ventilation with heliox.
Intervention typeOther
Primary outcome measureRespiratory system mechanics (compliance and resistance).
Secondary outcome measuresArterial partial pressure of Carbon Dioxide (pCO2).
Overall study start date01/10/2005
Completion date01/04/2007

Eligibility

Participant type(s)Patient
Age groupNeonate
SexNot Specified
Target number of participants15
Total final enrolment13
Key inclusion criteriaMechanically ventilated infants younger than 12 months of age with a virologically proven RSV infection.
Key exclusion criteriaOlder than 12 months of age, no informed consent, prior use of corticosteroids, infants on high-frequency oscillatory ventilation and infant wit a haemodynamically significant congenital heart defect.
Date of first enrolment01/10/2005
Date of final enrolment01/04/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center (The Netherlands)
University/education

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 15/05/2009 26/08/2021 Yes No

Editorial Notes

26/08/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.