A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns

Respiratory Failure Clinical Trial

— NeuroPAP  

Official title:

A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480205
• Other study ID #: CHUSJ-4083
• Status: Completed
• Phase: N/A
• First received: May 26, 2015
• Last updated: January 30, 2017
• Start date: August 2015
• Est. completion date: January 30, 2017

Study information

• Verified date: January 2017
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed. Considering that preterm infants are more likely to develop atelectasis, an active and ongoing management of the PEEP is very important to prevent de-recruitment.

A new respiratory support system (NeuroPAP) was developed to address these issues (synchronization problems and control the PEEP). It uses the electrical activity of the diaphragm (EDI) to control the ventilator assist continuously, both during inspiration (principle of NAVA mode) and also during expiration (based on tonic Edi level).

Description:

The mode NeuroPAP will work with the continuous Edi-level and deliver pressures according to the Edi-signal x set NeuroPAP-level, over the whole breath (inspiration and expiration). The NeuroPAP will work between two pressure levels set by the user and named higher Pressure limit (Plimit) and minimum Pressure (Pmin).

A safety upper pressure limit (UPL) will also be set. A backup ventilation will be possible.

A specific gastric tube equipped with an array of microelectrodes (Edi catheter, Maquet, Solna, Sweden) will be installed after inclusion, by the same oral or nasal route as the tube previously in place. Patients will then be ventilated in the 5 aforementioned conditions:

• On conventional NIPPV device on clinical settings for a 30 minute period. The investigators will note the mean airway pressure being delivered with the clinical settings and the resulting peak Edi, as well as neural respiratory rate, tonic Edi, Fraction of inspired oxygen (FiO2), and Oxygen saturation by pulse oximetry (SpO2).

• With NeuroPAP without modification of Pmin (=peep). The exchange of the nasal interface may be necessary, depending on the original interface. FiO2 will initially be the same as previously set in conventional NIPPV. The Pmin will initially be set at the level of PEEP used during conventional NIPPV. A titration maneuver will be conducted to identify the optimal NeuroPAP level. The infant will be ventilated for one hour. Clinical adjustments in pressures and FiO2 are permitted. Safety termination will be established.

• NeuroPAP with adjusted Pmin: the Pmin in NeuroPAP will be reduced by 2 cm H2O, with the same NeuroPAP level. The patients will be ventilated for one hour.

• CPAP delivery with NeuroPAP device: the device will be switched to CPAP mode, for a 15 minute period

• A second 30 minutes period of the conventional NIPPV will be conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 30, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• Preterm infants, >26 0/7 and < 34 weeks GA, at least 3 days old and younger than 1 month,

• on NIPPV with settings in the range : Maximal inspiratory pressure (total, including PEEP) < 20 cmH2O, and PEEP : 5-7 cmH2O,

• with FiO2 <40%, and stable.

Exclusion Criteria:

• Suspected or proven pneumothorax

• Patient on high-flow nasal cannula or nasal continuous positive airway pressure (nCPAP)

• Infants with severe recurring apnea

• Recent worsening of respiratory status with increase work of breathing, recent increase in FiO2, or linked with a suspected sepsis

• Contraindications to the placement of a new nasogastric tube (e.g. severe coagulation disorder, malformation or recent surgery in cervical, nasopharyngeal or esophageal regions)

• Hemodynamic instability requiring inotropes.

• Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 > 45%, or PaCO2 > 65 mmHg on blood gas in the last hour.

• Patient for whom a limitation of life support treatments is discussed or decided.

• Refusal by the treating physician.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• NeuroBox to deliver the NeuroPAP
The patients will be studied during the following conditions: On conventional NIPPV device with the clinically prescribed settings (30 min) With NeuroPAP and no change of Pmin (=peep) (60 min) With NeuroPAP and adjusted Pmin (decreased by 2 cmH2O) (60 min) During CPAP delivered with NeuroPAP device (15 min) Again with original NIPPV device and settings for 30 minutes

Locations

Country	Name	City	State
Canada	St. Justine's Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Justine's Hospital	Maquet Cardiovascular

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time effectively spent with NeuroPAP mode activated during the NeuroPAP period	Percentage	up to 30 minutes after reinstitution of the conventional NIPPV
Primary	Number of interruption of NeuroPAP during the NeuroPAP period	Number of interruption per patients	up to 30 minutes after reinstitution of the conventional NIPPV
Primary	Change in respiratory rates between standard NIV andNeuroPAP	% of change	up to 30 minutes after reinstitution of the conventional NIPPV
Primary	Change in cardiac rates between standard NIV andNeuroPAP	% of change	up to 30 minutes after reinstitution of the conventional NIPPV
Primary	Change in blood pressure between standard NIV andNeuroPAP	% of change	up to 30 minutes after reinstitution of the conventional NIPPV
Primary	Change in SpO2 between standard NIV andNeuroPAP	% of change	up to 30 minutes after reinstitution of the conventional NIPPV
Primary	Change in TcPCO2 between standard NIV andNeuroPAP	% of change	up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Time spent in asynchrony between standard NIV and NeuroPAP	% of time	up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in trigger delays (ms) between standard NIV andNeuroPAP		up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in non assisted breaths (wasted efforts) between standard NIV andNeuroPAP	% of change	up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in autotriggered breaths between standard NIV and NeuroPAP	Percentage	up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in Mean Airway pressure (cmH2O) between standard NIV and NeuroPAP		up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in End expiratory pressure (PEEP, cmH2O) between standard NIV and NeuroPAP		up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in Mean Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP		up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in Peak Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP		up to 30 minutes after reinstitution of the conventional NIPPV
Secondary	Change in Tonic Electrical activity of diaphragm (Edi, mcV) between standard NIV and NeuroPAP		up to 30 minutes after reinstitution of the conventional NIPPV