Respiratory Distress Syndrome Clinical Trial
Official title:
Observational, Cross-over Study of the Positive Distending Pressure Generated by Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
The specific aims of this study are to evaluate the amount of high flow nasal cannula (HFNC) gas flow required to generate an equivalent positive distending pressure as that provided by nasal continuous positive airway pressure (NCPAP) of 6 cm H2O, assess the relationships between positive distending pressure, gas flow, oxygen requirement, and patient weight, and lastly, develop an appropriate protocol to be used in the NICU for transitioning patients from NCPAP to an equivalent amount of HFNC.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 1) receiving NCPAP ventilatory support at > 72 hrs. of age and 2) requiring FiO2 21-50% on NCPAP. Exclusion Criteria: - FiO2 >50%, presence of pneumothorax or pleural effusion, anatomical abnormalities of the airway, lungs, or esophagus, or cyanotic congenital heart defect. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital and Clinics of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
Chang GY, Cox CA, Shaffer TH. Nasal cannula, CPAP, and high-flow nasal cannula: effect of flow on temperature, humidity, pressure, and resistance. Biomed Instrum Technol. 2011 Jan-Feb;45(1):69-74. doi: 10.2345/0899-8205-45.1.69. — View Citation
Fanaroff & Martin, Ch. 42, pg.1003
Gittermann MK, Fusch C, Gittermann AR, Regazzoni BM, Moessinger AC. Early nasal continuous positive airway pressure treatment reduces the need for intubation in very low birth weight infants. Eur J Pediatr. 1997 May;156(5):384-8. — View Citation
Jobe AH, Kramer BW, Moss TJ, Newnham JP, Ikegami M. Decreased indicators of lung injury with continuous positive expiratory pressure in preterm lambs. Pediatr Res. 2002 Sep;52(3):387-92. — View Citation
Lindner W, Vossbeck S, Hummler H, Pohlandt F. Delivery room management of extremely low birth weight infants: spontaneous breathing or intubation? Pediatrics. 1999 May;103(5 Pt 1):961-7. — View Citation
Locke RG, Wolfson MR, Shaffer TH, Rubenstein SD, Greenspan JS. Inadvertent administration of positive end-distending pressure during nasal cannula flow. Pediatrics. 1993 Jan;91(1):135-8. — View Citation
Ramanathan A, Cayabyab R, et al. High flow nasal cannula use in preterm and term newborns admitted to neonatal intensive care unit: a prospective, observational study. Pediatr Acad Soc 2005; 57:3417
Sreenan C, Lemke RP, Hudson-Mason A, Osiovich H. High-flow nasal cannulae in the management of apnea of prematurity: a comparison with conventional nasal continuous positive airway pressure. Pediatrics. 2001 May;107(5):1081-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean esophageal pressure | 3.5 hours | ||
Secondary | Vital signs | 3.5 hours |
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