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

NCT01381068 | Completed Results

• 1 other identifier: 090780
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delivery Room Resuscitation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PCO2 Level Outside of Desired Range (40-60 mmHg)

  This outcome will be obtained from the first available blood gas after admission to the NICU.

  Admission to NICU, approximately 1 hour of life

Secondary Outcomes (6)

• End Tidal CO2 Levels

  At the conclusion of resuscitation, approximately 15 minutes of life.

• Duration of Ventilation

  Duration of the hospital course, approximately 2-3 months

• Oxygen Use at 36 Weeks

  Hospital course, approximately 2-3 months

• Incidence of Pneumothorax/Airleak

  Hospital course, approximately 2-3 months

• Number of Patients Ventilated on NICU Admission

  On NICU admission, approximately 15 minutes of life

Study Arms (2)

Monitored Arm

EXPERIMENTAL

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.

Device: End tidal CO2 monitor

Control Arm

PLACEBO COMPARATOR

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.

Device: End tidal CO2 monitor

Interventions

End tidal CO2 monitor 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.

Also known as: NICO 2 Respiratory Profile Monitor (Respironics, Inc.)

Control Arm; Monitored Arm

Eligibility Criteria

• Age: Up to 15 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Need for ventilation in the delivery room

You may not qualify if:

• 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

Sponsors & Collaborators

• Neil Finer: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration; Hypercapnia; Hypocapnia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Results Point of Contact

• Title: Neil Finer
• Organization: UCSD

nfiner@ucsd.edu

Study Officials

• Tina A Leone, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: October 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-10

Locations

US (1)