Clinical trial NCT05332860: Extubation Times in Postoperative Congenital Cardiovascular Surgeries
Official title: Evaluation of Factors Affecting Extubation Times in Postoperative Congenital Cardiovascular Surgeries: A Randomized Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Congenital heart disease
perioperative management
pediatric cardiac surgery
extubation
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-04-18
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 72 patients

Brief summary: Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. The duration of postoperative mechanical ventilation is one of the most important factors affecting the process after pediatric cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there are opposing views that it causes an increase in complications; It caused disagreements about extubation times. In our study, we aimed to investigate the factors affecting extubation times after pediatric cardiac surgery.

Methods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass were included in our study. The patients were divided into 3 groups according to their extubation time. Those that were extubated in the operating room (OR) or in 6 hours after surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48 hours or not extubated (Delayed Extubation or DE). Many variables of preoperative, peroperative and postoperative periods were recorded to see which factors correlated with extubation times.

Detailed description: Children with critical congenital heart disease may need surgical or interventional procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to reduce the need for postoperative mechanical ventilation in order to minimize morbidity, provide optimal vital functions, and reduce unnecessary use of health resources. Researchers aimed to examine the relationships of perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in the hospital.

Eligibility criteria: Inclusion Criteria:

* elective or emergency patients
* aged 0-18 who are scheduled for congenital heart surgery

Exclusion Criteria:

-in patients who died during the operation

Primary outcomes:
measure: extubation times
timeFrame: 10 days after surgery
Secondary outcomes:
measure: mortality
timeFrame: on 10 days
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Training and Research Hospital
Study officials:
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Tuğba T Onur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Ümran Ü Karaca, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Anıl A Onur, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Mesut M Engin, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Asiye A Demirel, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Halil Erkan HE Sayan, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Şeyda Efsun ŞE Özgünay, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Nermin N Kılıçarslan, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Serkan S Seçici, MD
role: STUDY_CHAIR
affiliation: Bursa Yüksek İhtisas Education and Research Hospital
name: Selimcan S Yırtımcı, MD
role: STUDY_CHAIR
References: