Extubation Times in Postoperative Congenital Cardiovascular Surgeries

NCT05332860 | Completed

• 1 other identifier: Bursa Education Hospital
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease; perioperative management; pediatric cardiac surgery; extubation

Outcome Measures

Primary Outcomes (1)

• extubation times

  postoperative mechanical ventilation times

  10 days after surgery

Secondary Outcomes (1)

• mortality

  on 10 days

Study Arms (3)

Immediate Extubation or IE

patients were extubated in the operating room (OR) or in 6 hours after surgery

Procedure: Congenital Cardiovascular Surgery

Early Extubation or EE

patients were extubated within 6-48 hours of admission to the ICU

Procedure: Congenital Cardiovascular Surgery

Delayed Extubation or DE

patients were extubated sometime after 48 hours or not extubated

Procedure: Congenital Cardiovascular Surgery

Interventions

Congenital Cardiovascular Surgery PROCEDURE

Relationship between perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in our hospital.

Delayed Extubation or DE; Early Extubation or EE; Immediate Extubation or IE

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

72 patients

You may qualify if:

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

You may not qualify if:

• in patients who died during the operation

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Training and Research Hospital

Bursa, 16600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tuğba T Onur, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ümran Ü Karaca, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Anıl A Onur, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Mesut M Engin, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Asiye A Demirel, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Halil Erkan HE Sayan, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Şeyda Efsun ŞE Özgünay, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Nermin N Kılıçarslan, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Serkan S Seçici, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Selimcan S Yırtımcı, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 18, 2022
• Study Start: May 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: February 15, 2021
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

TU (1)