跳至主要内容
临床试验/CTRI/2024/05/067803
CTRI/2024/05/067803尚未招募不适用

Point of care ultrasound (POCUS) to detect diaphragmatic dysfunction in adult patients undergoing cervical spine surgery: A prospective observational study

Christian Medical College1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
135
试验地点
1
主要终点
Number of patients diagnosed to have diaphragmatic dysfunction by point-of-care ultrasound preoperatively and at 72 hours after surgery

研究概览

简要总结

Introduction

Perioperative diaphragmatic dysfunction is often an incidental diagnosis. It is most commonly reported in high-level traumatic cervical spinal cord injury patients where the cervical spinal cord ischemia is the cause and also in cardiothoracic surgeries where the aetiology is phrenic nerve injury. It is not well studied in chronic cervical myelopathies and cranio-vertebral junction anomalies, where both these mechanisms can cause diaphragmatic dysfunction. Diaphragmatic ultrasound is a bedside, user-friendly and non-invasive method to detect diaphragmatic dysfunction routinely used in critical settings to predict weaning failure in critically ill patients. In our study, we plan to screen for diaphragmatic dysfunction in all adult patients undergoing cervical spine surgery in the perioperative period with the help of diaphragmatic ultrasound. We also plan to study its association with preoperative respiratory function, clinical myelopathy grading and postoperative respiratory complications.

Purpose

In our study, we plan to look at the prevalence of diaphragmatic dysfunction in the population undergoing cervical spine surgery in our hospital. Our primary objective is to identify those with diaphragmatic dysfunction in the perioperative period. Secondarily, we plan to examine the association between patients’ functional status, including their functional grading, bedside pulmonary function tests, and diaphragmatic dysfunction on the ultrasound. We hope to identify risk factors for postoperative respiratory complications in these patients. This study aims to identify patients at risk for diaphragmatic dysfunction and plan perioperative management and optimisation strategies in these patients.

Study design: Prospective, observational study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adults aged ≥18 years ii.
  • Cervical spine surgery: Laminectomy, corpectomy, discectomy, cervical spine fusion surgery for degenerative/traumatic indications, cervical spinal tumours (extradural, intradural extramedullary and intramedullary) iii.
  • Surgery for Craniovertebral junction anomalies iv.
  • Cervical spine trauma requiring surgery v.
  • ASA 1, 2 and 3.

排除标准

  • i.Patient refusal ii.
  • Patients on mechanical ventilation in the preoperative period.
  • Patients with low Glasgow coma scale (less than 8) and unable to obey commands.
  • Patients with preexisting medical conditions causing respiratory dysfunction, including but not limited to Guillain Barre syndrome, motor neuron diseases, and bulbar poliomyelitis.
  • v.Prior history of cardiothoracic surgery vi.
  • Recent upper abdominal surgery in the past six weeks vii.
  • ASA 4 and 5.

结局指标

主要结局

Number of patients diagnosed to have diaphragmatic dysfunction by point-of-care ultrasound preoperatively and at 72 hours after surgery

时间窗: preoperative baseline | and postoperative 72 hours

次要结局

  • 1. Postoperative respiratory complications like respiratory failure, respiratory infections, respiratory distress, the requirement for non-invasive ventilation, reintubation, and prolonged mechanical ventilation within 30 days of discharge(2. Need for postoperative oxygen supplementation for more than 6 hrs.)

研究者

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

Dr.Bhargavi Vallabhaneni

Christian Medical college

研究点 (1)

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