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临床试验/CTRI/2026/02/103866
CTRI/2026/02/103866尚未招募不适用

Effect of different cervical spine pathologies on gastric emptying, using bed side ultrasound in adults patients- A prospective observational study.

M Nandini1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
144
试验地点
1

研究概览

简要总结

Cervical spine pathologies, both traumatic and non-traumatic, are associated not only with motor and sensory deficits but also with significant autonomic dysfunction, including gastrointestinal (GI) motility disturbances. Disruption of sympathetic outflow with preserved vagal tone may lead to delayed gastric emptying (DGE), increasing the risk of aspiration during anesthesia, particularly in patients with anticipated difficult airways. Despite the clinical relevance, there is limited literature comparing gastric emptying patterns across different cervical spine pathologies.

This prospective observational study aims to assess the effect of cervical spine diseases—classified as acute or chronic, traumatic or non-traumatic—on gastric emptying using bedside ultrasound. The study will recruit adult patients (aged 18–60 years) scheduled for elective cervical spine surgery, ASA I–II, over a period of one year at Nizam’s Institute of Medical Sciences. Exclusion criteria include emergency surgeries, ASA III–IV status, long-standing diabetes, chronic renal failure, GERD, BMI >40, polytrauma, and autonomic neuropathy.

Gastric volume will be assessed using a curvilinear probe (2–5 MHz) in the right lateral position. The antral cross-sectional area (ACSA) will be measured using anteroposterior and craniocaudal diameters, and gastric volume will be calculated using the Perlas formula:

Volume (mL) = 27 + 14.6 × ACSA (cm²) – 1.28 × age

Baseline gastric volume (after 8 hours fasting) and postprandial volume (4 hours after a standard breakfast) will be recorded. Each time, three ultrasound readings will be averaged. Additional variables including type and duration of cervical pathology, use of cervical collar, neurological deficits, and comorbidities will also be documented.

The study aims to identify high-risk subgroups requiring tailored fasting guidelines to optimize perioperative safety and minimize aspiration risk.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients with cervical spine pathology either acute or chronic and traumatic or non traumatic etiology scheduled for elective cervical spine surgery belonging to ASA class 1 and 2.

排除标准

  • High risk patients Emergency surgery Multiple comorbidities.

研究者

发起方
M Nandini
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr M NANDINI

Nizams institute of medical sciences

研究点 (1)

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