Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns
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|ClinicalTrials.gov Identifier: NCT02632825|
Recruitment Status : Unknown
Verified September 2015 by Research Center of Maternal and Child Health Protection, Armenia.
Recruitment status was: Recruiting
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Insufficiency||Device: Nasal High Flow||Not Applicable|
The aim of the study to investigate the effects of NHF therapy on ventilation and gas exchange during wakefulness and sleep in healthy term newborns.
NHF will be applied at 8 L/min (AIRVO 2) via (OPT 316) Optiflow nasal cannula interface without supplemental oxygen. Participants will act as their own control (no intervention) in a randomized crossover study design.
- Ventilation will be assessed using Respiratory Inductance Plethysmography (RIP) (Respitrace QDC, Viasys, USA).
- Blood carbon dioxide (CO2) and oxygen levels will be measured by a non-invasive transcutaneous monitor (Tosca, Radiometer, Demnark).
- All experiment will be recorded using Analogue-to-Digital converter (Powerlab, ADInstruments, New Zealand) and LabChart software with video recording of the patient.
- Sleep/awake statuss will be determined by videorecording of the patient and Electroencephalogram (EEG) (Alice Polysomnography System Philips, USA)
- The total study time will be <3 hours in total for each participant. Routine measurement of heart rate, respiratory rate and oxygen saturation will be performed as per standard neonatal clinical practice.
- Intervention can be terminated if at any time SpO2 drops below 80%, TcCO2 increases above 60 mm Hg, Respiratory Rate increases above 80 breaths per min for more than one minute).
The researcher is an experienced neonatal consultant will be conducting the research and observing the baby throughout the study.
Both control and NHF intervention periods will last a maximum of 40 min each. The maximum duration of the study including set-up, calibration, intervention, washout ans control will be <3 hours. At the beginning of the study when all probes are attached a self-calibration period of RIP will be followed by a calibration of breathing volume with a pneumotachometer attached to a nasal mask. After all calibrations are completed a baseline measurement will be followed by either NHF 8 L/min or a control period without NHF. At the end of this period the interventions will be changes either to control or NHF, which will follow by a washout period (no NHF) and an additional calibration of RIP with a pneumotachometer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange During Wakefulness and Sleep in Healthy Newborn Babies in a Randomized Crossover Study Design|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Nasal High Flow
NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen
Device: Nasal High Flow
Nasal High Flow Therapy
No Intervention: Control
Control is no NHF intervention
- Change of minute ventilation [ Time Frame: Up to 1 hour ]
- Blood carbon dioxide [ Time Frame: Up to 1 hour ]
- Oxygen levels [ Time Frame: Up to 1 hour ]
- Oxygen saturation [ Time Frame: Up to 1 hour ]
- Heart rate [ Time Frame: Up to 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632825
|Contact: Pavel Mazmanyan, MD, PhDemail@example.com|
|Contact: Stanislav Stanislav Tatkov, MD, PhD||+64212580270||Stanislav.Tatkov@fphcare.co.nz|
|Neonatal Intensive Care Unit, Research Centre of Maternal and Child Health||Recruiting|
|Yerevan, Armenia, 0002|
|Contact: Pavel Mazmanyan, Dr +37491 416589 firstname.lastname@example.org|
|Principal Investigator:||Pavel Mazmanyan, MD, PhD||Head of Neonatal Unit of Research Centre of Maternal and Child Health|