Risk Related Assistance During Stabilization In Newborns At Birth
- Conditions
- Infant, Newborn
- Interventions
- Other: Video recordingsOther: Video recordings after corrective measures in adverse events
- Registration Number
- NCT05023694
- Lead Sponsor
- Manuel Sanchez Luna
- Brief Summary
Approximately 10% of term infants and up to 50% of preterm infants less than 32 weeks require stabilization and / or ventilatory support at the time of transition at birth. Coordination between the rescuer team as well as the precise knowledge of protocol resuscitation maneuvers and indications, the communication of the various professionals involved (gynecologists, pediatricians and anesthesiologists) are critical for proper care and patient stabilization. Common adverse events may hinder or impair the effectiveness of these maneuvers, ventilation, monitoring, ... with consequent worsening in the prognosis of the newborn.
- Detailed Description
Patient safety is defined as reducing the risk of unnecessary harm associated with healthcare to an acceptable minimum, it is a task for all those involved in the care activity professionals, patients and managers. Since the incidents and adverse events involve a deficit in the quality of care causing damage to users and professionals, and increase healthcare costs, strategies should be to include both the detection and analysis of primary and secondary prevention.
The video recording programs are considered useful to monitor and detect problems during resuscitation and is believed to be useful for improving resuscitation.
HYPOTHESIS Principal: The mismatch in compliance with the guidelines for neonatal resuscitation is the main type of incident during resuscitation due to inadequate stabilization times . The cause of these incidents during resuscitation is varied and not only focuses on personal failure.
As a second hypothesis is that: the implementation of a protocol , after analysis of errors, minimizes by more than 15 % possible incidents and reduces the trip times.
EVALUATION Data collection will be made prospectively. Management during stabilization of the newborn in the delivery room with video is recorded by an independent contributor or fixed camera. Physiological parameters such as air pressure, gas flow , tidal volume , heart rate and oxygen saturation are monitored and recorded in the software monitor respiratory function and analog data FiO2
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- the newborns, who require stabilization at birth in delivery room
- reanimation unrecorded with video
- no obtained informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Newborn reanimated video recordings Video recordings Newborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent Newborn reanimated video recordings Video recordings after corrective measures in adverse events Newborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent
- Primary Outcome Measures
Name Time Method Identify number and types of adverse events through study completion, an average of 1 year Improve safety and thus the quality of health care in the stabilization and resuscitation of the newborn in Delivery Room by identifying and preventing risks related to patient care.
- Secondary Outcome Measures
Name Time Method Number of income in Neonatal Unit after resuscitation through study completion, an average of 1 year NICU income
Preventive measures to limit incidents through study completion, an average of 1 year Optimize a protocol on stabilizing the newborn.
Advanced reanimations through study completion, an average of 1 year Number of advanced resuscitation
Trial Locations
- Locations (1)
HGU Gregorio Marañón Madrid
🇪🇸Madrid, Spain