Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth

Preterm Infant Clinical Trial

— SenSyNoPP  

Official title:

Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399914
• Other study ID #: 310/2021BO1
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2022
• Source: University Hospital Tuebingen
• Contact: Springer Laila, MD, PD
• Phone: +4970712982224
• Email: laila.springer[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this prospective observational study (pilot study) is to test if synchronized noninvasive positive pressure ventilation (S-NIPPV) is feasible and works appropriately during transition from intrauterine to extrauterine life in very preterm infants in the delivery room.

Description:

The study period will be the first 10 minutes after birth.

All patients will be non-invasively ventilated using an EVE NEO ventilator (CE 0482, Fritz Stephan GmbH, Gackenbach, Germany). A facemask will be used throughout the study period. Synchronization will be achieved using graseby capsule (Stephan, Vio Healthcare), which will be secured at the abdominal wall on the midaxillary line below the ribs. For the detection of spontaneous breaths respiratory induction plethysmography (RIP) is used. For this purpose, an extra small plethysmography belt (Sleepsense, Elgin, USA) is placed around the abdomen. The data of the plethysmography belts are processed and stored with the NewLifebox-XL (Advanced Life Diagnostics UG, Weener, Germany) and merged with the data from the ventilator for later evaluation.

Infants according to the clinician's assessment only needing CPAP will receive S-NIPPV with very low PIP levels. This enables to have enough ventilator breaths applied for analysis to obtain sufficient data about the synchronization rate of S-NIPPV in the delivery room and meanwhile consider the infant's safety by not applying high pressures where it might not be needed. The ventilator support settings will be PIP 10, PEEP 6 in the noninvasive pressure controlled assist control ventilation (nPC-ACV+) mode. In this mode every spontaneous breath is supported by a ventilator breath (if the triggering level is exceeded). The triggering level will be set at 0,5 to avoid autotriggering and unsupported breaths. The inspiratory time will be set at max. 0,3 sec. The backup ventilation rate is set at 60 per minute.The EVE NEO ventilator has in the nPC-ACV+ mode an option where the ventilator breaths are interrupted/stopped as soon as the graseby capsule detects a start of spontaneous expiration.

If the infant according to the clinician's assessment needs S-NIPPV (e.g. the infant is apnoeic, and/or heart rate is below 100 bpm), the pressure of S-NIPPV will be augmented to target PIP 20, PEEP 6 (unless clinical concerns require an adjustment). The respiratory support can be deescalated to PIP 10 once the clinician deems the higher pressure no longer necessary.

The following demographical characteristics will be collected from the patient charts (pseudonymized): gender, gestational age, birth weight, antenatal steroids, mode of delivery, reason for prematurity (prolong premature rupture of membrane, infection, pathologic CTG, pathological doppler, gestosis), time of cord clamping, umbilical cord pH, FiO2 requirement, APGAR.

The following interventions within the first 10 minutes after birth including the time will be noted: tactile stimulation, placement of an intravenous line, non-invasive surfactant administration, intubation, chest compression, administration of volume, catecholamine, blood or other medication.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Preterm infants with a gestational age (GA) between 26 = and < 32 weeks

Exclusion Criteria:

• Major congenital malformations

• Refused parental consent (prenatal parental consent is necessary)

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant
• Respiratory Support

Intervention

Other:
• S-NIPPV
Synchronized noninvasive positive pressure ventilation during the first 10 minutes after birth.

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Synchronisation rate	Synchronisation rate (sensitivity/true positive rate) of S-NIPPV in the delivery room meaning the proportion of graseby triggered synchronized ventilator breaths with corresponding RIP signal related to all spontaneous breaths detected by RIP.	First 10 minutes after birth
Secondary	False negative rate	Proportion of non-synchronized ventilator breaths with corresponding RIP signal. This will be related to all spontaneous breaths detected by RIP.	First 10 minutes after birth
Secondary	False positive rate	Proportion of graseby triggered ventilator breaths without corresponding RIP signal. This will be related to all ventilator breaths without a corresponding RIP signal (i.e. movement artefacts).	First 10 minutes after birth
Secondary	Proportion of artifacts	Proportion of graseby triggered ventilator breaths without corresponding RIP signal. This will be related to all ventilator breaths.	First 10 minutes after birth
Secondary	Specificity (true negative rate)	Proportion of ventilator breaths without corresponding RIP signal and with no graseby signal (i.e. during an apnoea). This will be related to all ventilator breaths without a corresponding RIP signal.	First 10 minutes after birth
Secondary	Proportion of back up breaths	Proportion of ventilator breaths without corresponding RIP signal and with no graseby signal. This will be related to all ventilator breaths.	First 10 minutes after birth
Secondary	Proportion of time of synchronised breaths, non-synchronized breaths, periods of apnoea and periods of movement artefacts occure within the first ten minutes of respiratory support.		First 10 minutes after birth
Secondary	Time until the graseby capsule is attached to the infant's abdomen and the proportion of infants in whom the graseby capsule is attached within the first two minutes after birth.		First 10 minutes after birth
Secondary	Proportion of time non invasive ventilator breaths will be applied.		First 10 minutes after birth
Secondary	Peak inspiratory pressure (PIP)		First 10 minutes after birth
Secondary	Positive end expiatory pressure (PEEP)		First 10 minutes after birth
Secondary	Mean airway pressure (MAP)		First 10 minutes after birth
Secondary	Td (time delay) graseby	Time between the initial increase of the abdominal RIP curve and the initial increase of the graseby curve.	First 10 minutes after birth
Secondary	Td (time delay) ventilator	Time between the initial increase of the graseby curve and the beginning of the pressure curve.	First 10 minutes after birth
Secondary	Ti ventilator	Inspiratory time of a ventilator breath	First 10 minutes after birth
Secondary	Ti RIP	Inspiratory time of a spontaneous breath	First 10 minutes after birth
Secondary	Ti excess	Calculated: ((Ti ventilator - Ti RIP)/Ti RIP)) x 100	First 10 minutes after birth
Secondary	Swing RIP	Amplitude of the RIP curve calculated by subtracting the baseline RIP from the peak RIP curve, which is a surrogate parameter for the patient's respiratory effort.	First 10 minutes after birth
Secondary	Number of tactile stimulations and other interventions on the patient	Number of tactile stimulations and other interventions on the patient (e.g. placement of intravenous line, non-invasive administration of surfactant, intubation, chest compression) are documented by video analysis.	First 10 minutes after birth
Secondary	Heart rate		First 10 minutes after birth
Secondary	Oxygen saturation		First 10 minutes after birth
Secondary	Fraction of inspired oxygen		First 10 minutes after birth