跳至主要内容
临床试验/CTRI/2025/05/087303
CTRI/2025/05/087303尚未招募不适用

Difficult airway prediction using Clinical and Ultrasound airway assessment parameters:A Prospective Observational Study

Christian Medical College1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
175
试验地点
1
主要终点
Predictive Value of Ultrasound Airway Assessment in Difficult Airway

研究概览

简要总结

Difficult Airway Prediction is an important part of pre anaesthesiaassessment as it facilitates planning and preparing to manage a difficultairway. This in turn will enable a smooth perioperative course and reducedperioperative morbidity. Conventional physical assessment for difficult airwaycan sometimes fail to identify a difficult airway. This has made Point of CareUltrasonography (POCUS) as an evolving tool for airway assessment.

In this study, both Male and Female Patients above 18yrs ofAge, Classified as per American Society of Anaesthesiologist as ASA1,ASA 2,posted for Elective Surgeries planned under General Anaesthesia usingendotracheal intubation are included. Pregnant women, Patients with knownairway (Oral, pharyngeal, Laryngeal) pathologies, Cervical Vertebral diseases,Large Thyroid and Parathyroid Swelling, Submandibular Salivary Gland Pathology,Healed Post Tracheostomy scar, Post Burn Contractures of Neck, or any scar overthe neck and patients posted for Oro-Pharyngeo-Laryngeal procedures andEmergency surgeries are excluded from this study.

In this study, after consent for the study, the airwayphysical assessment using SARI scoring is evaluated preoperatively.Preoperatively (before Intubation) On the day of Surgery, in the operatingroom, the primary investigator or  co-investigator shall measure Distance fromSkin to Epiglottis (DSE)and Hyomental Distance (HMD)  with neck neutral, extended and in rampedpositions ,and tongue thickness (TT) using ultrasound, thus completing thetests in the DARES protocol. It is planned that 15% of Sample size  done by the Primary Investigator shall bevalidated by Radiologist – Co Investigator. . If the Primary investigator’sassessment is not comparable to Radiologist - Co Investigator, then patientsassessed by Primary investigator prior shall be dropped and the PrimaryInvestigator shall be undergoing further training with the co – investigator.Post Training Primary Investigator will continue the study.

The Senior Anaesthesiologist posted on the elective list whois not aware of  the recorded SARI scoreand DARES protocol measurements will intubate the patient and record the IDSscore obtained.

POCUS predictive value in Difficult Airway Assessment usingthe DARES protocol, will be calculated and compared with conventional physicalairway assessment using the SARI score The difficulty of  airway management will be calculated based onthe IDS score.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adults above 18yrs of age , classified as ASA1 and ASA 2 undergoing Elective Surgeries- Plastics Surgeries, Gynaecology Surgeries, Urology Surgeries, General Surgeries, Ortho Surgeries, ENT surgeries under General Anaesthesia in CMC Town Campus and Ranipet Campus requiring intubation for surgeries.

排除标准

  • Anticipated Difficult Airway-Pregnant women,Patients with known airway-Oral, pharyngeal, Laryngeal pathologies, Cervical Vertebral diseases, Large Thyroid and Parathyroid Swelling, Submandibular Salivary Gland Pathology, Healed Post Tracheostomy scar, Post Burn Contractures of Neck, or any scar over the neck and patients posted for Oro-Pharyngeo-Laryngeal procedures , Emergency surgeries,Mentally Challenged, Superspeciality Surgery – Neuro Surgery, Cardiothoracic Surgery are excluded from this study.

结局指标

主要结局

Predictive Value of Ultrasound Airway Assessment in Difficult Airway

时间窗: At time of Induction

次要结局

  • Predictive Value of Clinical Airway Assessment in Difficult Airway(At time of Intubation)
  • Comparison of Predictive Value of ultrasound Airway assessment with Clinical Airway Assessment for Difficult Airway Prediction(NIL)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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