跳至主要内容
临床试验/CTRI/2021/12/038382
CTRI/2021/12/038382已完成不适用

Clinical Outcome of Perioperative Airway and Ventilatory Management in Patients undergoing Surgery for Oral Cavity Cancer - a Prospective, Observational Study

All India Institute of Medical Sciences Bhopal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月12日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Description of frequency and type of procedures used in establishing a secure airway during oral cavity oncosurgical procedures as well as the duration and type of ventilatory support needed by the patients in the postoperative period

研究概览

简要总结

Cancer of the oral cavity is a heterogeneous group of pathologies. Oral cancers may have origin from various sites such as the lip, floor of the mouth, tongue, alveolar ridge, retromolar gingiva, hard palate, and buccal mucosa.

Globally, oral cancers have a high incidence among all malignancies. In India almost 30% of newly detected malignancies annually are due to oral cancers.

Surgery is the preferred modality of initial treatment in locoregionally advanced oral cavity cancers. Malignant involvement of the oral cavity often poses a challenge to the anaesthesiologist. Oral cancer patients commonly present with ‘difficult airway’ which is conventionally defined as ‘the clinical situation in which a conventionally trained anaesthesiologist experiences difficulty with facemask ventilation of the upper airway, difficulty with tracheal intubation, or both’. Factors responsible include distortion of upper airway anatomy by tumour, decreased inter-incisor gap, and fixation of soft tissue of upper airway by surgical scarring or fibrosis. Prior radiation therapy might lead to restricted mouth opening and limited neck movements. Routine methods of airway management during general anaesthesia are usually not sufficient in such patients.

Apart from difficult airway, other concerns include shared airway, prolonged surgery and postoperative airway oedema.

A detailed assessment of airway is of prime importance in oral cancer patients both in the pre-anaesthetic checkups as well in the pre-operative setting. Careful planning and execution would reduce perioperative morbidity and length of hospital stay.

In this study, we aim to describe the frequency and type of procedures used in establishing a secure airway, and the duration and type of postoperative ventilatory support needed by the patients undergoing surgery for oral cancers. We also aim to observe the effect of airway management techniques on the immediate clinical outcome by assessing the length of postoperative intensive care unit stay. A study to this effect would allow us to better evaluate and manage such patients and predict outcomes in the perioperative period. Hence this study has been planned

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients 18-65 years of age 2) Patients with ASA I-III 3) Patients undergoing oral cavity oncosurgeries under general anaesthesia.

排除标准

  • Patients where surgery did not proceed 2) Patients who could not be followed up.

结局指标

主要结局

Description of frequency and type of procedures used in establishing a secure airway during oral cavity oncosurgical procedures as well as the duration and type of ventilatory support needed by the patients in the postoperative period

时间窗: From perioperative period till end of ICU/HDU stay

次要结局

  • Evaluation of effect of airway and ventilatory management techniques on postoperative length of ICU/HDU stay(From perioperative period till end of ICU/HDU stay)
  • Comparison of data with findings of the TRACHY study(From perioperative period till end of ICU/HDU stay)

研究者

申办方类型
Government medical college

研究点 (1)

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