Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study

Lung-protective Ventilation Clinical Trial

Official title:

Optimization of Ventilation Strategies in Preterm and Term Infants in a Single-center Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512689
• Other study ID #: 1334/2022
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: November 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a non-blinded, non-randomized intervention study in a single-center clinical setting, analyzing ventilation quality with and without RFM visibility.

Description:

The study was conducted at the Neonatal Intensive Care Unit and the delivery room at the Division of Neonatology, at the Medical University of Vienna. We aimed to record ventilation parameters (tidal volume, mask leak, ventilation rate, PIP, PEEP) using a CE-certified Respiratory Function Monitor (Neo100, Monivent AB, Gothenburg, Sweden), which was either hidden or visible to the provider responsible for the airway (airway provider), during ventilations on term and preterm patients at the NICU and the delivery room. The investigators aimed to determine the quality of ventilations performed by healthcare professionals depending on RFM visibility. Analysis occurred, determining whether observing the data displayed on the RFM during PPV of preterm and newborn infants lead to adjustments in applied pressure and an increase in the proportion of inflations performed within a predefined range of 4-8 ml/kg for VTe. The investigators hypothesized that using a RFM with numeric and graphical display of values during positive pressure ventilation of infants will lead to i) more frequent recognition and correction of tidal volumes outside the predefined range and ii) reduction of mask leak. This knowledge gain may improve future training using a RFM to improve the quality of ventilations and, thereby, patient safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Patients at the Neonatal Intensive Care Unit (NICU) and in the delivery room who receive positive pressure ventilation
• Written consent from parents or legal guardians of patients
• Preterm and term infants (male and female, any gestational age)

Exclusion Criteria:

• Healthcare professionals or parents/legal guardians, representing their children, that do not consent to participation in this study

Related Conditions & MeSH terms

• Lung-protective Ventilation

Intervention

Device:
• Ventilations while using a respiratory function monitor
Healthcare professionals are able to use a feedback device to guide their ventilations.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of ventilations with VTe between 4-8ml/kg	percentage of ventilations within range divided through all ventilations performed, for each participant	through study completion, an average of 1 year
Secondary	Mean value for mask leak and proportion of ventilations with excessive mask leak (defined as >50%) during all ventilations	defined as > 50%	through study completion, an average of 1 year
Secondary	Occurrence of insufficient tidal volume (defined as <4mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)	defined as < 4ml/kg	through study completion, an average of 1 year
Secondary	Occurrence of excessive tidal volume (defined as >8mL/kg) as a proportion of ventilations given (face mask and endotracheal tube)	defined as > 8ml/kg	through study completion, an average of 1 year
Secondary	Mean value for ventilation rate (defined as ventilations per minute)	defined as ventilations per minute	through study completion, an average of 1 year
Secondary	Mean value for peak inflation pressure	defined as > 35 cmH2O	through study completion, an average of 1 year
Secondary	Outcome data and adverse events	this included diagnoses (i.e., bronchopulmonary dysplasia [BPD], persistent ductus arteriosus [PDA], IVH, periventricular leukomalacia [PVL], and pneumothorax) and the time frame of occurrence (within 24 hours, one week, or during the total hospital stay). BPD was defined as the need of any respiratory support at the GA of 36 weeks, evaluated for infants below 32+0 weeks GA. IVH was determined using the DEGUM classification	through study completion, an average of 1 year
Secondary	Comparison of elective versus delivery room interventions	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison	through study completion, an average of 1 year
Secondary	Comparison of fellows vs. consultants	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison	through study completion, an average of 1 year
Secondary	Comparison of sef-inflating-bag vs. neo-T	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison	through study completion, an average of 1 year
Secondary	Comparison of ventilations via face mask vs. endotracheal tube	mean values for all evaluated ventilation parameters (VTe, leak, PIP, rate) for this comparison	through study completion, an average of 1 year