Impact of Laryngeal Mask Airway Versus Endotracheal Intubation on Mechanical Power and Postoperative Respiratory Complications in Pediatric Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mechanical power (MP)
研究概览
简要总结
This prospective observational study aims to compare two commonly used airway management methods-Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT)-in pediatric patients undergoing elective surgery under general anesthesia. The primary objective is to evaluate the impact of LMA and ETT on intraoperative mechanical power, an emerging indicator of ventilator-induced lung stress. Secondary objectives include assessing postoperative respiratory complications such as cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding episodes. No interventions will be assigned based on a study protocol; airway management will be determined solely by clinical requirements. Routine ventilator parameters will be recorded, and mechanical power will be calculated using a validated simplified formula.
详细描述
This prospective, observational, single-center clinical study will be conducted in the Department of Anesthesiology and Reanimation at Konya City Hospital. The aim of the study is to compare the effects of Laryngeal Mask Airway (LMA) and Endotracheal Intubation (ETT) on intraoperative mechanical power in pediatric patients aged 2-5 years undergoing elective surgical procedures under general anesthesia. Mechanical power, calculated from routinely measured ventilator parameters, reflects the energy delivered to the respiratory system and is considered an important marker of ventilator-induced lung injury. Understanding how different airway devices influence mechanical power may contribute to improving lung-protective ventilation strategies in pediatric anesthesia.
Randomization will not be applied in this study. Airway management (LMA or ETT) will be chosen solely by the attending anesthesiologist based on clinical needs, including procedure type, expected duration, and aspiration risk. A standardized anesthesia induction and maintenance protocol will be applied to all patients. Mechanical power will be measured at two time points: (1) immediately after securing the airway and (2) at the end of surgery before emergence. Postoperative respiratory complications-including cough, hypoxemia, laryngospasm, bronchospasm, increased secretions, and breath-holding-will be systematically recorded in the Post-Anesthesia Care Unit (PACU).
To minimize observer bias, intraoperative mechanical power measurements and postoperative complication assessments will be performed by different members of the research team. No deviations from routine clinical practice will occur, and no additional interventions will be introduced. Based on the power analysis for the primary outcome, the study aims to include a total of 100 pediatric patients, with 50 patients in the LMA group and 50 patients in the ETT group.
The findings of this research are expected to provide new insights into the effects of different airway devices on mechanical power and to support the development of lung-protective anesthesia strategies in pediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2-5 years
- •Body weight between 10-20 kg
- •Patients classified as ASA physical status I-III
- •Elective surgery planned under general anesthesia
排除标准
- •Presence of severe chronic lung disease (e.g., advanced bronchopulmonary dysplasia)
- •Uncontrolled or severe bronchial asthma
- •Severe cardiac failure (NYHA Class III-IV)
- •Diagnosis of pulmonary hypertension
- •History of major lung surgery
- •Severe obesity (BMI > 95th percentile)
- •Children scheduled for abdominal or thoracic surgery
- •Procedures expected to last longer than two hours
- •Emergency surgeries
- •Children and/or parents who decline participation in the study
研究组 & 干预措施
Group 1: LMA Group
Group 2: ETT Group
干预措施: Laryngeal Mask Airway (LMA) (Procedure)
结局指标
主要结局
Mechanical power (MP)
时间窗: Mechanical power will be measured twice during surgery, as follows: MP1: Immediately after airway placement, before the start of surgery. MP2: At the end of surgery, before the initiation of emergence.
To compare the effects of laryngeal mask airway (LMA) and endotracheal intubation (ETT) on intraoperative mechanical power (MP) in pediatric patients aged 2-5 years undergoing elective surgery under general anesthesia. Mechanical power (MP) will be assessed using ventilator-derived respiratory parameters (tidal volume, respiratory rate, PEEP, peak pressure, and plateau pressure). MP will be calculated using the following validated equation: Mechanical Power (J/min) = 0.098 × RR × VT × (PEEP + ½(Pplat - PEEP) + (Ppeak - Pplat)).
次要结局
- Postoperative Respiratory Complications(From the start of emergence until discharge from PACU (assessed up to approximately 30 minutes).)
- Postoperative Respiratory Complications(From the start of emergence until discharge from PACU (assessed up to approximately 60 minutes).)
研究者
Esma Karaarslan
Medical Doctor (MD), Department of Anesthesiology and Reanimation, Konya City Hospital
Konya City Hospital