Chest Compression and Sustained Inflation

NCT ID: NCT02083705

Last Updated: 2025-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.

Detailed Description

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Conditions

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Newborn Infants Having Asystole or Bradycardia at Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SI+CC

Chest compression will be superimposed by sustained inflations during CPR:

"CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.

Group Type EXPERIMENTAL

CC+SI

Intervention Type PROCEDURE

Chest compression will be superimposed by sustained inflation during CPR

3:1 CPR

CPR using 3:1 C:V ratio:

"3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.

Group Type ACTIVE_COMPARATOR

3:1 CPR

Intervention Type PROCEDURE

CPR using 3:1 ratio (control group)

Interventions

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CC+SI

Chest compression will be superimposed by sustained inflation during CPR

Intervention Type PROCEDURE

3:1 CPR

CPR using 3:1 ratio (control group)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria

\-
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georg Schmolzer

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.

Reference Type DERIVED
PMID: 28988159 (View on PubMed)

Other Identifiers

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Pro00034524_CC

Identifier Type: -

Identifier Source: org_study_id

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