跳至主要内容
临床试验/CTRI/2026/02/103276
CTRI/2026/02/103276尚未招募不适用

Evaluation of Optimal Tracheal Tube Cuff Pressure Using Stethoscope-Guided Inflation and Expired-to-Inspired Tidal Volume Ratio Technique in Pediatric Patients Aged 2-7 Years: A Prospective Randomized Controlled Trial

Indira Gandhi Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2026年2月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
195
试验地点
1

研究概览

简要总结

Endotracheal intubation in pediatric anesthesia requires careful management of the endotracheal tube (ETT) cuff pressure to ensure an adequate airway seal while minimizing the risk of tracheal mucosal injury. Unlike adults, children have a more delicate airway mucosa with lower mucosal capillary perfusion pressure, rendering them especially susceptible to ischemic damage from excessive cuff pressures. Maintaining ETT cuff pressures below 20 cm H2O is widely recommended in pediatrics to balance effective ventilation against the risk of mucosal injury and subsequent postoperative airway complications such as cough, sore throat, and subglottic edema. This study hypothesizes that the expired-to-inspired tidal volume ratio technique will yield superior outcomes in achieving optimal cuff pressures with a lower incidence of post-extubation cough compared to the stethoscope-guided inflation method in pediatric patients aged 2 to 7 years.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Pediatric patients aged 2 to 7 years.
  • Patients scheduled for elective surgery requiring general anesthesia with endotracheal intubation.
  • Use of cuffed endotracheal tube (size appropriate for age and weight).
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Written informed consent obtained from parent or legal guardian.

排除标准

  • Anticipated difficult airway or difficult intubation (e.g., known or suspected difficult mask ventilation or laryngoscopy) b.
  • History of recent upper respiratory tract infection c.
  • Congenital or acquired craniofacial abnormalities or airway deformities, d.
  • History of prematurity or currently preterm neonates.
  • Pre-existing respiratory diseases such as asthma, bronchospasm, or reactive airway disease.
  • Cardiac conditions that may complicate anesthesia.
  • Emergency surgeries or procedures not allowing adequate preoperative evaluation.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Annu Choudhary

Indira Gandhi Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验