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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NL198 (NTR235) |
| Sponsor | VU University Medical Center (The Netherlands) |
| Funder | Not provided at time of registration |
- 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
Scientific
VU Medical Centre
Office 8 D 11
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2413 |
|---|---|
| m.kneyber@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, crossover group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Respiratory system mechanics and electrical impedance tomography measurements during mechanical ventilation with heliox in infants with respiratory syncytial virus lower respiratory tract disease |
| Study objectives | 1. 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) studied | Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV LRTD) |
| Intervention | Mechanical ventilation with heliox. |
| Intervention type | Other |
| Primary outcome measure(s) |
Respiratory system mechanics (compliance and resistance). |
| Key secondary outcome measure(s) |
Arterial partial pressure of Carbon Dioxide (pCO2). |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 15 |
| Total final enrolment | 13 |
| Key inclusion criteria | Mechanically ventilated infants younger than 12 months of age with a virologically proven RSV infection. |
| Key exclusion criteria | Older 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 enrolment | 01/10/2005 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
