Respiratory Disease Clinical Trial
Official title:
Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce Hypoxic Events? A Randomised Controlled Crossover Study in Ventilated Infants
NCT number | NCT05017727 |
Other study ID # | 298164 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2021 |
Est. completion date | January 17, 2023 |
Verified date | September 2023 |
Source | King's College Hospital NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases mortality and later disability whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm and low birth weight infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplementary oxygen. Therefore, they may suffer from complications related to hypoxia or hyperoxia. Hence, their oxygen saturation levels and the amount of the inspired oxygen concentration provided should be continuously monitored. Oxygen control is traditionally monitored and adjusted manually by the nurse looking after the infant. Closed-loop automated oxygen control (CLAC) is a more recent approach that involves the use of a computer software incorporated into the ventilator. The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range, decreases the duration of hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. However previous studies have been limited to very small infants. With this study the investigators aim to evaluate the effectiveness of CLAC in ventilated infants born at 34 weeks gestation and beyond. The achievement of oxygen saturation targets and the number of manual adjustments required will be compared between periods of CLAC and manual control in a cohort of patients that has not been included in previous studies and could also benefit from the intervention. The investigators will also evaluate if CLAC reduces investigations performed to ventilated babies(blood gases, X-rays).
Status | Completed |
Enrollment | 31 |
Est. completion date | January 17, 2023 |
Est. primary completion date | January 17, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 34 Weeks and older |
Eligibility | Inclusion Criteria: - Infants born at 34 weeks completed gestation and above requiring mechanical ventilation and admitted to King's NICU - Any gender, ethnicity or other comorbidities Exclusion Criteria: - Preterm infants less than 34 weeks gestation - Infants with cyanotic congenital heart disease - Infants undergoing planned procedures or surgery during the monitoring period - Infants on high frequency oscillatory ventilation (HFOV) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
King's College Hospital NHS Trust | King's College London |
United Kingdom,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The decrease in the percentage of time spent in extremes of hypoxia | That will be assessed by evaluating the infant's respiratory status. | Over 24 hours | |
Secondary | The increase in the percentage of time spent within target oxygen saturation ranges (94-98%) | This will be assessed by evaluating the infant's respiratory status. | Over 24 hours | |
Secondary | The reduction in the number of manual adjustments required to the inspired oxygen concentration | That will be assessed by reviewing the infant's medical records | Over 24 hours | |
Secondary | The reduction in the number of blood gases and chest radiographs | That will be assessed by reviewing the infant's medical records | Over 24 hours |
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