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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01962818
Registration number
NCT01962818
Ethics application status
Date submitted
9/10/2013
Date registered
14/10/2013
Date last updated
22/03/2023
Titles & IDs
Public title
High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance.
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Scientific 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
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Secondary ID [1]
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1936M
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome In Premature Infants
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Bronchopulmonary Dysplasia
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Ventilator-Induced Lung Injury
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Functional Residual Capacity
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
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Complications of newborn
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Injuries and Accidents
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - HFOV combined with sigh breaths
Experimental: HFOV-sigh at start - Each patient will be exposed to either HFOV alone (HFOV-only) or HFOV combined with sigh breaths (HFOV-sigh), but in different order.
MAP=mean airway pressure.
DURING HFOV-SIGH:
Frequency 3 breaths/min Ti = 1s Peak inspiratory pressure (PIP) = 30 cm H2O
For patients already on HFOV-sigh at study start:
• MAP-set will be left unchanged at pre-trial settings.
For patients on HFOV-only at study start:
• During periods with superimposed sigh breaths, MAP-set will be reduced in accordance with a calculation of MAP aiming to keep average mean airway-pressure (MAP) unchanged. (MAP=(PIP\*Tinsp+PEEP\*Texp)/(Tinsp+Texp)
DURING HFOV-ONLY
For patients on HFOV-sigh at study start:
• During HFOV-only, the MAP-set will be increased in accordance with a calculation of MAP, aiming to keep average mean airway-pressure (MAP) unchanged.
For patients on HFOV-only at study start:
• MAP-set will be left unchanged at pre-trial settings.
Experimental: HFOV-only at start - Each patient will be exposed to either HFOV alone (HFOV-only) or HFOV combined with sigh breaths (HFOV-sigh), but in different order.
MAP=mean airway pressure.
DURING HFOV-SIGH:
Frequency 3 breaths/min Ti = 1s Peak inspiratory pressure (PIP) = 30 cm H2O
For patients already on HFOV-sigh at study start:
• MAP-set will be left unchanged at pre-trial settings.
For patients on HFOV-only at study start:
• During periods with superimposed sigh breaths, MAP-set will be reduced in accordance with a calculation of MAP aiming to keep average mean airway-pressure (MAP) unchanged. (MAP=(PIP\*Tinsp+PEEP\*Texp)/(Tinsp+Texp)
DURING HFOV-ONLY
For patients on HFOV-sigh at study start:
• During HFOV-only, the MAP-set will be increased in accordance with a calculation of MAP, aiming to keep average mean airway-pressure (MAP) unchanged.
For patients on HFOV-only at study start:
• MAP-set will be left unchanged at pre-trial settings.
Other interventions: HFOV combined with sigh breaths
It is planned only to investigate infants already ventilated on the HFOV-modus on high frequency oscillators, where the HFOV modus can be superimposed on conventional modes of ventilation. This gives the opportunity to combine HFOV with intermittent sigh breaths with a pre-set frequency and pre-set peak inspiratory pressure (PIP) and thus comparing HFOV combined with sigh breaths (HFOV-sigh) with conventional HFOV (HFOV-only).
All included participants will be exposed to the two different ventilator strategies tested in this trial, albeit in alternating and different order.
Each patient will serve, as it's own control. The trial will involve four alternating 1-hours periods allowing a sufficient "wash-out" period, as it has been shown that alveolar recruitment and derecruitment may take up to 25 min after changes to ventilator pressures At study start the patients will randomly be assigned to either starting with HFOV-only or HFOV-sigh
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Global changes in end expiratory lung volume (EELV)
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Assessment method [1]
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Relative difference in EELV expressed as difference in end-expiratory lung impedance during HFOV-only and HFOV-sigh
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Timepoint [1]
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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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Primary outcome [2]
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Regional ventilation distribution
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Assessment method [2]
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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.
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Timepoint [2]
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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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Secondary outcome [1]
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Global changes in oscillatory volume (Vosv):
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Assessment method [1]
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Relative difference in oscillatory volume expressed as change in impedance amplitude during HFOV-only and HFOV-sigh, if measurable
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Timepoint [1]
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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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Secondary outcome [2]
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Regional difference in oscillatory volume
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Assessment method [2]
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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
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Timepoint [2]
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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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Secondary outcome [3]
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Regional distribution of sigh-breaths volume
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Assessment method [3]
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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
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Timepoint [3]
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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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Secondary outcome [4]
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Global inhomogeneity index
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Assessment method [4]
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Calculated for oscillatory volume and tidal volume during sigh breaths respectively
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Timepoint [4]
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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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Secondary outcome [5]
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Phase angle analyses
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Assessment method [5]
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* 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.
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Timepoint [5]
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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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Secondary outcome [6]
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vital parameters during HFOV-sigh vs HFOV-only
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Assessment method [6]
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relative changes in fraction of inspired oxygen (FiO2), oxygensaturation and heart rate
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Timepoint [6]
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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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Eligibility
Key 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
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Minimum age
24
Weeks
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Maximum age
44
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2023
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Department of Neonatology, Mater Mothers Hospital - Brisbane
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Recruitment postcode(s) [1]
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4101 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Rigshospitalet, Denmark
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01962818
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christian Heiring, neonatologist
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Address
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Department of Neonatology, Rigshospitalet, Copenhagen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01962818
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