Optimisation of invasive breathing support in newborns by continuous carbon dioxide monitoring

Not Applicable

Completed

• Conditions: Mechanical ventilation in newborns; Respiratory

• Registration Number: ISRCTN12331315
• Lead Sponsor: King's College Hospital

Brief Summary

2020 Results article in https://doi.org/10.1002/ppul.24738 (added 25/01/2022) 2021 Results article in https://doi.org/10.1038/s41390-021-01388-8 (added 25/01/2022) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33649438/ (added 25/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-01
• Study Completion: 2021-12-31
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Neonates
2. Invasively mechanically ventilated
3. Admitted to the neonatal intensive care unit
4. Written parental consent

Exclusion Criteria

1. Non ventilated infants
2. Infants on non-invasive respiratory support

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Decrease in the complications of mechanical ventilation and decrease in the frequency of blood sampling in ventilated newborn infants.; Timepoint(s): .<br> The following are recorded throughout the period the infant is receiving invasive mechanical ventilation:<br> 1. Frequency of complications of mechanical ventilation (pneumothorax, blocked or dislodged endotracheal tube, hypo or hypercarbia),<br> 2. Frequency of routine blood gas sampling<br> These will be compared to historical controls who were invasively mechanically ventilated prior to the use of routine end tidal capnography monitoring.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Validation of side stream capnography with mainstream capnography and arterial carbon dioxide levels, ascertained by correlation of values in kPa during a twenty-minute validation period<br> 2. Anatomical and alveolar dead space, calculated in mechanically ventilated infants with four neonatal respiratory conditions:<br> 2.1. Respiratory distress syndrome<br> 2.2. Evolving bronchopulmonary dysplasia<br> 2.3. Meconium aspiration syndrome<br> 2.4. Persistent pulmonary hypertension of the newborn<br> These will be calculated by analysing carbon dioxide waveforms using the Bohr/Enghoff equation once the infant is no longer receiving mechanical ventilation.<br>