Chronic Respiratory Failure
Conditions
Keywords
nasal non-invasive ventilation, RAM Cannula, Pediatric Complex Care, Tracheostomy Avoidance
Brief summary
The purpose of this study is to implement a standardized protocol to initiate nasal non-invasive ventilation with RAM nasal cannula (NIV/RAM-NC) with Trilogy mechanical ventilator at Children Memorial Hospital inpatient and outpatient sites, as well as to explore the side effects and complications associated with the use of NIV/RAM-NC in children.
Interventions
DEVICENasal non-invasive ventilation with RAM cannula
Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 21 Years
Healthy volunteers
No
Inclusion criteria
* Children admitted to the Children Memorial Hermann Hospital and consulted to Pediatric Pulmonary Service for initiation of NIV/RAM-NC both at the inpatient and outpatient sites. * Children who fail to wean from chronic respiratory support (CPAP, BiPAP, HFNC) in whom long-term ventilation is considered between 10/2016 - 10/2017 will be included.
Exclusion criteria
* Children with minimal setting (CPAP \< 5cmH2O, HFNC \< 3LPM) able to be weaned to regular nasal cannula. * Patients with upper airway obstruction that may be candidates for surgical procedure will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Assessed by Number of Participants Who Had Complications | 7 days after starting the RAM cannula | Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasal Non-invasive Ventilation With RAM Cannula Nasal non-invasive ventilation with RAM cannula: Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Nasal Non-invasive Ventilation With RAM Cannula |
|---|---|
| Age, Continuous | 5.92 years STANDARD_DEVIATION 7.75 |
| Race/Ethnicity, Customized African American | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Region of Enrollment United States | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Feasibility as Assessed by Number of Participants Who Had Complications
Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.
Time frame: 7 days after starting the RAM cannula
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Non-invasive Ventilation With RAM Cannula | Feasibility as Assessed by Number of Participants Who Had Complications | 0 Participants |