Trial Outcomes & Findings for Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting (NCT NCT03473171)

Results Overview

Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

7 days after starting the RAM cannula

Results posted on

2020-03-24

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting

Baseline characteristics by cohort
Measure	Nasal Non-invasive Ventilation With RAM Cannula n=5 Participants 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.
Age, Continuous	5.92 years STANDARD_DEVIATION 7.75 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Race/Ethnicity, Customized African American	3 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian	1 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=99 Participants
Region of Enrollment United States	5 Participants n=99 Participants

Timeframe: 7 days after starting the RAM cannula

Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.

Outcome measures
Measure	Nasal Non-invasive Ventilation With RAM Cannula n=5 Participants 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.
Feasibility as Assessed by Number of Participants Who Had Complications	0 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

The University of Texas Health Science Center at Houston

Phone: 713-500-5650