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Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants

NCT02528851 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-08-19

No results posted yet for this study

Summary

The aim of this study is to compare the cardiovascular and respiratory effects of "higher" versus "equivalent" CPAP pressures post-extubation from high endotracheal airway pressures (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure (MAP) \[if on high frequency ventilation\] or positive end-expiratory pressure (PEEP) \[if on conventional ventilation\] at time of extubation. Participants will be randomized to "higher" CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We hypothesize that "higher" CPAP levels, when compared to "equivalent" CPAP levels, do not adversely impact the cardiorespiratory status when a patient is extubated from high EAP.

Conditions

  • Preterm Infant

Interventions

PROCEDURE

Extubation from endotracheal mechanical ventilation to CPAP

Following randomization, the infants will be extubated to the "higher" CPAP group (CPAP level 2cm H2O higher than extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) based on their allocation.

Sponsors & Collaborators

Principal Investigators

  • Souvik Mitra, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-05-31
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02528851 on ClinicalTrials.gov