Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room (CO2-Vent)

The University of Texas System (UT)

Status: Enrolling

Conditions: Neonatal Disease; Neonatal Resuscitation

Treatments: Device: Pedi-Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT06258187

STU-2023-0969

Details and patient eligibility

About

The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation.

A randomization generator will assign each month to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room facemask PPV.

Full description

This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR > 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics.

In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.

Enrollment: 632 estimated patients

Sex: All

Ages: 30+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants born at ≥30 weeks' gestation
• Presence of the resuscitation team prior to delivery
• Need for non-invasive positive pressure ventilation (PPV).

Exclusion criteria

• Infants born at <30 weeks' gestation
• No non-invasive PPV needed in the delivery room
• Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
• Resuscitation team not present prior to delivery/need for PPV
• Infants who have a prenatal plan of comfort care only

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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632 participants in 2 patient groups

Pedi-Cap

Experimental group

Description:

A Pedi-Cap will be connected to the T-piece resuscitator in between the T-piece and face mask. With effective gas exchange, carbon dioxide (CO2) is detected by the Pedi-cap and will demonstrate gold color change with each exhalation. If there is no CO2 gas exchanged, the Pedi-Cap color will remain purple. The color change will be used as one of the tools for the resuscitation team to determine if the infant has effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation. Other ways, in addition to the Pedi-Cap, to determine effective PPV include a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation.

Treatment:

Device: Pedi-Cap

No Pedi-Cap

No Intervention group

Description:

There will be no Pedi-Cap attached to the t-piece resuscitator. Effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation will be assessed by a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation.