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Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)

NCT ID: NCT01381068

Last Updated: 2019-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.

Detailed Description

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Conditions

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Delivery Room Resuscitation

Keywords

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ventilation end tidal carbon dioxide hypercapnia hypocapnia positive pressure ventilation neonates delivery room resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monitored Arm

The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55.

Group Type EXPERIMENTAL

End tidal CO2 monitor

Intervention Type DEVICE

The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.

Control Arm

The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment.

Group Type PLACEBO_COMPARATOR

End tidal CO2 monitor

Intervention Type DEVICE

The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.

Interventions

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End tidal CO2 monitor

The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.

Intervention Type DEVICE

Other Intervention Names

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NICO 2 Respiratory Profile Monitor (Respironics, Inc.)

Eligibility Criteria

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Inclusion Criteria

* Need for ventilation in the delivery room

Exclusion Criteria

* Tracheal suctioning for meconium
* Congenital Diaphragmatic Hernia
* Suspected hypoplasia of the lungs
* Oligohydramnios \<28 weeks gestation or AFI\<5
* Known or suspected airway anomaly
* Mother not speaking English or Spanish
* Refusal of consent
Maximum Eligible Age

15 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neil Finer

OTHER

Sponsor Role lead

Responsible Party

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Neil Finer

Professor Emeritus

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tina A Leone, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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UCSD Medical Center

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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090780

Identifier Type: -

Identifier Source: org_study_id