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临床试验/NCT06627660
NCT06627660尚未招募不适用

Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty

Sameh Fathy0 个研究点目标入组 58 人开始时间: 2024年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
Sameh Fathy
入组人数
58
主要终点
Incidence of laryngospasm

研究概览

简要总结

We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.

Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay

详细描述

Congenital Laryngomalacia is the main cause of stridor in newborns and infants, affecting 45-75% of all infants with congenital stridor. Short aryepiglottic folds, redundant arytenoid, omega-shaped epiglottis, and inspiratory stridor are features of laryngomalacia. Pediatric laryngospasm is a glottic closure due to reflex constriction of the laryngeal muscles that produce partial or complete obstruction of the larynx. When complete and sustained, laryngospasm is considered an anesthetic Emergency.

The valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec, after which the pressure is suddenly released and the breathing restored to normal.

We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.

After approval of IRB, Mansoura University, this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals. After obtaining a written informed consent from patients parents, random number generator with closed envelope technique will randomize patients into two groups [control] group ( C group ), Valsalva group ( V group)].

Anesthesia will be induced by inhalational induction using sevoflurane at concentration (6:8%). After that, a proper sized cannula will be introduced with giving atropine 0,01mg/kg and hydrocortisone 4mg/ kg. Then, patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology. After that, proper sized ETT will be inserted using succinylcholine 1mg\kg IV and fixed in place after confirmation of correct positioning , with maintenance of anesthesia with isoflurane. All patients will be given 0.5-1mic /kg fentanyl and 15 mg /kg paracetamol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty

排除标准

  • Parents refusal.
  • Patients with increased ICP
  • Patients with increased IOP

结局指标

主要结局

Incidence of laryngospasm

时间窗: 24 HOURS

次要结局

  • incidence of reintubation(24 HOURS)
  • Postoperative oxygen saturation measurement(1 HOUR)
  • Incidence of postoperative nausea and vomiting(24 HOURS)
  • Duration of postoperative hospital stay(24 HOURS)

研究者

发起方
Sameh Fathy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sameh Fathy

Sameh Mohamed Fathy El-Sherbiny, MD, Assistant Professor at Mansoura Faculty of Medicine

Mansoura University

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