Bronchopulmonary Dysplasia Clinical Trial
Official title:
High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths in Neonates Compared With Standard High Frequency Oscillatory Ventilation - Effects on Lung Volume Monitored by Electric Tomography Impedance
NCT number | NCT01962818 |
Other study ID # | 1936M |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | January 1, 2023 |
Verified date | March 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV ("open lung concept") could reduce lung injury. "Open lung HFOV" is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. Electric Impedance Tomography (EIT) enables measurement and mapping of regional ventilation distribution and end-expiratory lung volume (EELV). EIT generates cross-sectional images of the subject based on measurement of surface electrical potentials resulting from an excitation with small electrical currents and has been shown to be a valid and safe tool in neonates. Purpose, aims: - To compare HFOV-sigh with HFOV-only and determine if there is a difference in global and regional EELV (primary endpoints) and spatial distribution of ventilation measured by EIT - To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that EELV during HFOV-sigh is higher, and that regional ventilation distribution is more homogenous. Methods: Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV will remain at pretrial settings. 16 ECG-electrodes for EIT recording will be placed around the chest at study start. Each recording will last 180s, and will be done at baseline and at 30 and 50 minutes after each change in ventilator modus. Feasibility No information of EIT-measured EELV in babies on HFOV-sigh exists. This study is a pilot-trial. In a similar study-protocol of lung recruitment during HFOV-sigh using "a/A-ratio" as outcome, 16 patients was estimated to be sufficient to show an improvement by 25%. This assumption was based on clinical experience in a unit using HFOV-sigh routinely. As the present study examines the same intervention we assume that N=16 patients will be a sufficient sample size. We estimate to include this number in 6 months.
Status | Completed |
Enrollment | 16 |
Est. completion date | January 1, 2023 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Weeks to 44 Weeks |
Eligibility | Inclusion Criteria: - Infants at 24-36 weeks corrected gestational age - Already ventilated with high frequency ventilation - Requiring FiO2=21%-70% to maintain adequate oxygen saturation. - Clinical stable o i.e. ventilated on current settings for more than just a few hours with stable but not necessarily normalized blood gases or transcutaneous values and oxygen requirement. - Parent(s) or guardian able and willing to provide informed consent Exclusion Criteria: • Major congenital cardiovascular or respiratory abnormalities (excluding Patent ductus arteriosus). - Poor skin integrity precluding use of adhesive ECG electrodes used for EIT monitoring. - The physician responsible for the baby considers one of the ventilation modes unsuitable for the infant or the patient unsuitable for EIT monitoring. - Lack of parental signed written informed consent or if both parents are under 18 years of age (due to complexities of obtaining consent). |
Country | Name | City | State |
---|---|---|---|
Australia | Department of Neonatology, Mater Mothers Hospital | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global changes in end expiratory lung volume (EELV) | Relative difference in EELV expressed as difference in end-expiratory lung impedance during HFOV-only and HFOV-sigh | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Primary | Regional ventilation distribution | Relative difference in regional EELV during HFOV-sigh vs HFOV-only expressed as change in regional end-expiratory lung impedance in predefined regions of interests (ROI), such as e.g. ventral, mid-ventral, mid-dorsal and dorsal lung areas. | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Secondary | Global changes in oscillatory volume (Vosv): | Relative difference in oscillatory volume expressed as change in impedance amplitude during HFOV-only and HFOV-sigh, if measurable | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Secondary | Regional difference in oscillatory volume | Relative difference in regional oscillatory volume expressed as change in impedance amplitude during HFOV-only and HFOV-sigh in predefined regions of interests (ROI), such as e.g. ventral, mid-ventral, mid-dorsal and dorsal | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Secondary | Regional distribution of sigh-breaths volume | Regional distribution of sigh-breaths during HFOV-sigh based on impedance amplitude of sigh-breaths in predefined ROIs, such as e.g. ventral, mid-ventral, mid-dorsal and dorsal | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Secondary | Global inhomogeneity index | Calculated for oscillatory volume and tidal volume during sigh breaths respectively | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Secondary | Phase angle analyses | Description of regional filling characteristic by phase angle analysis, measuring synchronicity of emptying and filling of different lung regions during sigh-breaths.
Aim to analyse if a possible increase in EELV during HFOV-sigh is distributed to different ROIs with different timing. |
all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. | |
Secondary | vital parameters during HFOV-sigh vs HFOV-only | relative changes in fraction of inspired oxygen (FiO2), oxygensaturation and heart rate | all data for the outcome is collected on the study day. Calculations and analyses will be done within 6 months from the study day. |
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