跳至主要内容
临床试验/CTRI/2025/07/091681
CTRI/2025/07/091681尚未招募不适用

A prospective observational study on CSF lumbar drain placement for endoscopic CSF leak repair in patients diagnosed with spontaneous CSF leak

christian medical college and hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
The time taken for placement of the LSAD with the two different techniques

研究概览

简要总结

Measurement and monitoring of intracranial pressure play vital roles in diagnostic and therapeutic procedures. Different methods of measuring intracranial pressure involve both invasive and noninvasive techniques. Both invasive and non-invasive techniques of intracranial pressure monitoring have their advantages and disadvantages. Out of all the techniques of measurement of intracranial pressure, measurement of ICP via lumbar puncture/ drain is one of the less invasive techniques. But lumbar puncture / lumbar catheter placement needs expertise, and it is time consuming.The purpose of our study is to formulate a protocol / guide in performing a lumbar puncture/ lumbar drain placement procedure. One of the major priorities will be in reducing the time requirement while performing the procedure. There are different techniques of placement of lumbar drain catheter. We would like to observe and formulate a protocol which suggests the technique with minimal duration, decreasing the number of attempts of placement. We would also like to observe the technique with minimal hemodynamic changes.Patients posted for Spontaneous CSF leak repair and patients requiring preoperative lumbar drain placement between age groups 18- 75 years of age, in the ASA classification I TO III will be approached for informed consent by the principal investigator on the evening prior to surgery and recruited.Preoperatively patient’s demographics, diagnosis, the proposed surgery, the indication for lumbar drain placement, comorbidities of the patient, examination of the patient and the baseline investigations will be assessed and documented by the principal investigator. Standard fasting guidelines will be followed by and premedication if indicated will be given with tablet lorazepam/tablet diazepam. In the operating theatre, a peripheral line which is a part of the routine anesthetic procedure will be started.In the operating room IV access will be established under local anaesthesia and ASA (American Society of Anaesthesiologists) standard monitoring will be established with SpO2, ECG, NIBP and EtCO2. The baseline vitals (heart rate, blood pressure, skin temperature, consciousness level) will be recorded. Vital signs will be monitored during the procedure (every 5 minutes) for the complete duration of the surgery and the monitoring will be continued in the recovery room, till the time the patient is ready for discharge from the post anaesthesia care unit. The CSF pressure during the lumbar drain placement will be recorded and documented. Continuous temperature recording will be done.We will also record the technique of lumbar drain placement, the position of the patient, procedure done under either local anaesthesia/ general anaesthesia, the type and gauge of the needle used for the catheter placement, the number of attempts of placement, any complications during the procedure. The total duration of the procedure, the amount of CSF drained every hour (intra-operatively), the intraoperative blood loss during the surgery. Postoperatively if the patient is stable, they will be shifted to the post-anesthesia care unit (PACU) or recovery room for immediate post-operative monitoring. If the patient requires continued hemodynamic and ventilatory care, ICU admission will be mandated. This will be documented. Post-operative parameters: In the post-operative period, we will follow up on the patient till the day the lumbar drain catheter is removed. We will observe, assess and document the following postoperative details such as the total volume of CSF drained, any complications such as kinking, occlusion of the catheter, blood-tinged CSF in the catheter and the number of postoperative days that the catheter is kept in situ.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA I, II and III Patients between 18-75 years of age Elective CSF LEAK REPAIR surgery.

排除标准

  • ASA 4 and above emergency surgery patient refusal age more than 80 years.

结局指标

主要结局

The time taken for placement of the LSAD with the two different techniques

时间窗: Intra-operative and the post-operative periods.

being used ( USG and landmark based techniques).

时间窗: Intra-operative and the post-operative periods.

次要结局

  • Number of attempts required for LSAD placement using two different techniques (USG or(landmark based technique))

研究者

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

Rahavi R

CHRISTIAN MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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