Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
Primary Purpose
Respiratory Distress Syndrome, Cronic Lung Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring HFNC, NCPAP, nasal continuous positive airway pressure, humidified high flow nasal cannula, esophageal pressure, gas flow
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital and Clinics of Minnesota
Outcomes
Primary Outcome Measures
Mean esophageal pressure
Secondary Outcome Measures
Vital signs
Full Information
NCT ID
NCT00356668
First Posted
July 24, 2006
Last Updated
July 13, 2015
Sponsor
Children's Hospitals and Clinics of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00356668
Brief Title
Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
In the face of exogenous surfactant and use of antenatal steroids, respiratory distress syndrome (RDS) remains a leading cause of morbidity and mortality in premature infants. RDS is the result of a series of complex, interrelated events, including atelectasis, ventilation-perfusion mismatching, and lung inflammation/injury (1). The cascade of events which typifies RDS and its long-term counterpart, chronic lung disease (CLD), is rooted in the intrinsic deficits of the premature lung as well as exacerbated by mechanical ventilation, a mainstay of therapy. For this reason, scientists and clinicians alike continue to search for treatment modalities which will not only treat RDS but also decrease the incidence of chronic lung disease.
The use of non-invasive ventilatory strategies, such as nasal continuous positive airway pressure (NCPAP), in the treatment of RDS is thought to provide positive distending pressure while minimize lung inflammation and injury associated with mechanical ventilation (2). Avoidance of intubation and increased use of NCPAP to treat respiratory distress syndrome has been shown to decrease the incidence of chronic lung disease (3,4). However, NCPAP does have some common clinical limitations. First, the administration of NCPAP has inherent mechanical difficulties in appropriately maintaining the nasal prong apparatus within the small neonatal nose. Secondly, the nasal prongs used to deliver NCPAP can cause nasal septal trauma. Lastly, some premature infants do not tolerate the NCPAP apparatus which must be tightly affixed to their nose and face. This intolerance is often demonstrated by increased patient movement, and subsequently, the risk of mechanical difficulties and septal trauma increase during these times. Although NCPAP continues to be used in most neonatal intensive care units (NICUs), due to its aforementioned drawbacks, we continue to look for other effective, non-invasive modes of ventilation to provide support to premature infants with respiratory distress.
Humidified high flow nasal cannula (HFNC) has recently been introduced into neonatal respiratory care as a means of providing positive distending pressure to the neonate with respiratory distress. HFNC aims to maximize patient tolerance by employing heated, humidified gas flow through the standard neonatal nasal cannula that is used routinely in neonatal intensive care units. HFNC provides positive distending pressure by using high gas flow (>1 liter per minute) (5). Although numerous neonatal intensive care units are using HFNC, including both NICUs at Children's Hospitals of Minnesota, there are very few studies regarding its use in this population. Anecdotally, the premature babies tolerate the administration of HFNC quite well. However, like any new therapy, there are many unknowns.
There is only one study to date which investigates HFNC versus NCPAP in the preterm neonate (6). Sreenan and colleagues found HFNC to be as effective as NCPAP in the management of apnea of prematurity and also demonstrated that the positive distending pressure provided by HFNC varied with the patient's weight. Sreenan's study as well as preliminary data presented in abstract form cite HFNC use with various amounts of gas flow, ranging from 1 liter per minute up to 6 liters per minute (6,7,8). The choice of how much gas flow to use with the HFNC system is unclear. This decision is actually a three-fold question: 1) the initial amount of liter flow to use, 2) what does a particular liter flow provide for positive distending pressure to that patient, and 3) are these values system-specific? We aim to evaluate these questions in our study. Until recently, NCPAP has been the mainstay of non-invasive ventilatory support for premature babies. However, as HFNC is better tolerated and uses a nasal cannula that is less prone to mechanical mishaps than NCPAP, it is clear that we need more information to accurately treat babies with HFNC. The results of this study will help guide the use of HFNC in preterm babies with respiratory insufficiency, as knowledge of the positive distending pressures derived from the HFNC system are crucial in minimizing barotrauma to the fragile, premature lung.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Cronic Lung Disease
Keywords
HFNC, NCPAP, nasal continuous positive airway pressure, humidified high flow nasal cannula, esophageal pressure, gas flow
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula
Intervention Description
30 minute blocks on varying flows of high flow nasal cannula
Primary Outcome Measure Information:
Title
Mean esophageal pressure
Time Frame
3.5 hours
Secondary Outcome Measure Information:
Title
Vital signs
Time Frame
3.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark C Mammel, MD
Organizational Affiliation
Children's Hospital and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Fanaroff & Martin, Ch. 42, pg.1003
Results Reference
background
PubMed Identifier
12193673
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. doi: 10.1203/00006450-200209000-00014.
Results Reference
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PubMed Identifier
10224173
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. doi: 10.1542/peds.103.5.961.
Results Reference
background
PubMed Identifier
9177982
Citation
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. doi: 10.1007/s004310050620.
Results Reference
background
PubMed Identifier
8416477
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.
Results Reference
background
PubMed Identifier
11331690
Citation
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. doi: 10.1542/peds.107.5.1081.
Results Reference
background
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
Results Reference
background
PubMed Identifier
21322815
Citation
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.
Results Reference
background
PubMed Identifier
18760803
Citation
Lampland AL, Plumm B, Meyers PA, Worwa CT, Mammel MC. Observational study of humidified high-flow nasal cannula compared with nasal continuous positive airway pressure. J Pediatr. 2009 Feb;154(2):177-82. doi: 10.1016/j.jpeds.2008.07.021. Epub 2008 Aug 30.
Results Reference
derived
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Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure
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