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Clinical Trials/CTRI/2025/05/087303
CTRI/2025/05/087303Not yet recruitingNot Applicable

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

Christian Medical College1 site in 1 country175 target enrollmentStarted: February 6, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
175
Locations
1
Primary Endpoint
Predictive Value of Ultrasound Airway Assessment in Difficult Airway

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Predictive Value of Ultrasound Airway Assessment in Difficult Airway

Time Frame: At time of Induction

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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