Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621641
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Intensive Care Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes of a Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Critical Bronchiolitis Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bronchiolitis is a leading cause of pediatric hospital admissions Despite its limited clinical benefits the use of HFNC in children with bronchiolitis is increasing
Previous studies using quality improvement QI methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Childrens Hospital involving infants aged 1-24 months admitted with bronchiolitis
Previous studies using quality improvement QI methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Childrens Hospital involving infants aged 1-24 months admitted with bronchiolitis
Detailed Description:
Bronchiolitis is a leading cause of pediatric hospital admissions While high-flow nasal cannula HFNC is effective as a rescue therapy for patients with severe respiratory distress when standard oxygen therapy fails studies suggest that early use of HFNC in moderate cases does not significantly improve outcomes such as hospital stay duration or intubation rates Despite its limited clinical benefits the use of HFNC in children with bronchiolitis is increasing raising concerns about unnecessary treatment and extended hospital stays due to a lack of standardized weaning protocols
Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails serving as an intermediate step before invasive support However the high costs and self-limiting nature of bronchiolitis necessitate reducing the overuse of HFNC in hospitalized children Previous studies using quality improvement QI methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Childrens Hospital involving infants aged 1-24 months admitted with bronchiolitis A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale RAS with mild moderate and severe classifications The study compares HFNC duration hospital stay oxygen support duration and associated costs before and after the protocol implementation
Exclusion Criteria
Premature infants born at less than 32 weeks Patients with cardiopulmonary genetic congenital or neuromuscular abnormalities were excluded
A prospective randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC High-Flow Nasal Cannula weaning protocol in infants aged 1-24 months with bronchiolitis compared to the standard weaning protocol
The new HFNC weaning protocol was developed using Quality Improvement QI methodology involving input from pediatricians nurses and hospital staff through training sessions The training lasted one month before the implementation focusing on classifying patients using the Respiratory Assessment Scale RAS which includes respiratory rate the workload of breathing and consciousness level A multidisciplinary team will apply the protocol
Protocol for Bronchiolitis in Children Under 2 Years
Aspiration postural drainage hydration antipyretics if necessary nasal cannula for SpO₂ drop 3-4 Lmin
Despite nasal cannula 3 LPM FiO₂ 32 hypoxemia 92 FiO₂ or moderate-to-severe RAS
Yes Start HFNC High-Flow Nasal Cannula therapy No Continue with HFNC or nasal cannulamask
HFNC Therapy Initiation
Initial FiO₂ 50 Flow rate 1-2 Lkg Target SpO₂ between 92-96 by titrating FiO₂ Calculate the baseline ROX index
Reassess in 30-60 minutes
Is there clinical deterioration Moderate-to-severe RAS
If clinical deterioration is present
FiO₂ 50 SpO₂ 90 pCO₂ 60 Positive pressure ventilation should be considered if there is apnea or bradycardia
If there is no clinical deterioration
After 4 hours of stable condition reassess Is there improvement in RAS and ROX index and is the patient clinically stable
Yes
If FiO₂ 30 start weaning the flow rate and FiO₂ simultaneously Reduce the flow rate by 2 Lmin every 2-4 hours and evaluate the RAS-ROX trend every 2-4 hours
If there is respiratory deterioration
Continue or increase HFNC flow rate and FiO₂ as needed
If there is no respiratory deterioration
Weaning continues Discontinue HFNC when the flow rate reaches 4 Lmin and FiO₂ 30
Is there respiratory deterioration
Yes
Return to the previous flow rate and reassess within 30 minutes
Randomization and Groups
Participants will be randomly assigned to one of two groups
Control Group Will follow the existing HFNC weaning protocol Intervention Group The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol
Outcomes
The 2 groups will be compared regarding HFNC duration hospital stay oxygen support duration intensive care readmission noninvasive ventilation NIV needs intubation rates and costs
Evidence suggests that HFNC should be used effectively as a rescue treatment after standard oxygen therapy fails serving as an intermediate step before invasive support However the high costs and self-limiting nature of bronchiolitis necessitate reducing the overuse of HFNC in hospitalized children Previous studies using quality improvement QI methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy
This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Childrens Hospital involving infants aged 1-24 months admitted with bronchiolitis A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale RAS with mild moderate and severe classifications The study compares HFNC duration hospital stay oxygen support duration and associated costs before and after the protocol implementation
Exclusion Criteria
Premature infants born at less than 32 weeks Patients with cardiopulmonary genetic congenital or neuromuscular abnormalities were excluded
A prospective randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC High-Flow Nasal Cannula weaning protocol in infants aged 1-24 months with bronchiolitis compared to the standard weaning protocol
The new HFNC weaning protocol was developed using Quality Improvement QI methodology involving input from pediatricians nurses and hospital staff through training sessions The training lasted one month before the implementation focusing on classifying patients using the Respiratory Assessment Scale RAS which includes respiratory rate the workload of breathing and consciousness level A multidisciplinary team will apply the protocol
Protocol for Bronchiolitis in Children Under 2 Years
Aspiration postural drainage hydration antipyretics if necessary nasal cannula for SpO₂ drop 3-4 Lmin
Despite nasal cannula 3 LPM FiO₂ 32 hypoxemia 92 FiO₂ or moderate-to-severe RAS
Yes Start HFNC High-Flow Nasal Cannula therapy No Continue with HFNC or nasal cannulamask
HFNC Therapy Initiation
Initial FiO₂ 50 Flow rate 1-2 Lkg Target SpO₂ between 92-96 by titrating FiO₂ Calculate the baseline ROX index
Reassess in 30-60 minutes
Is there clinical deterioration Moderate-to-severe RAS
If clinical deterioration is present
FiO₂ 50 SpO₂ 90 pCO₂ 60 Positive pressure ventilation should be considered if there is apnea or bradycardia
If there is no clinical deterioration
After 4 hours of stable condition reassess Is there improvement in RAS and ROX index and is the patient clinically stable
Yes
If FiO₂ 30 start weaning the flow rate and FiO₂ simultaneously Reduce the flow rate by 2 Lmin every 2-4 hours and evaluate the RAS-ROX trend every 2-4 hours
If there is respiratory deterioration
Continue or increase HFNC flow rate and FiO₂ as needed
If there is no respiratory deterioration
Weaning continues Discontinue HFNC when the flow rate reaches 4 Lmin and FiO₂ 30
Is there respiratory deterioration
Yes
Return to the previous flow rate and reassess within 30 minutes
Randomization and Groups
Participants will be randomly assigned to one of two groups
Control Group Will follow the existing HFNC weaning protocol Intervention Group The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol
Outcomes
The 2 groups will be compared regarding HFNC duration hospital stay oxygen support duration intensive care readmission noninvasive ventilation NIV needs intubation rates and costs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None