NCT05414214

Brief Summary

The study is designed to evaluate the validity of the SMDD as a predictor of difficult airway in elderly and to compare its validity with that of the TMHT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

June 8, 2022

Last Update Submit

September 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • sensitivity, specificity of the sternomental displacement as a predictor of difficult laryngoscopy in elderly surgical patients.

    10 minutes

Secondary Outcomes (5)

  • Thyromental Height Test (TMHT)

    10 minutes

  • Sternomental displacement (SMDD)

    10 minutes

  • Modified Mallampati test (MMT)

    10 minutes

  • Cormack-Lehane (CL) grading system

    10 minutes

  • The number and duration of intubation attempts

    10 minutes

Study Arms (1)

Elderly

Elderly patients who are scheduled for elective surgeries under general anesthesia with endotracheal intubation accomplished using conventional laryngoscopy will be included.

Procedure: Thyromental Height TestProcedure: Sternomental displacementProcedure: General anesthesia

Interventions

Thyromental Height Test (TMHT) : will be measured while a patient is lying supine with the head and neck are maintained in a neutral position using a pillow under the head. By using a digital depth gauge, the TMH is the vertical distance measured between the anterior border of the thyroid cartilage directly on the thyroid notch and the anterior border of the mentum.

Elderly

Sternomental displacement (SMDD): While the patient is sitting with the head in a neutral position, SMD-neutral will be measured using a tape as the distance between upper borders of the manubrium sterni and the mentum. The SMD-extension will then be measured in the same way with the head extended on the neck. The difference between SMD-extension and SMD-neutral will then be calculated as SMDD.

Elderly

patients will be pre-oxygenated with 100% oxygen for 3 minutes, anesthesia will be then induced intravenously using fentanyl 2 μg/kg, propofol 1 -1.5 mg/kg, and succinylcholine 1 mg/kg lean body weight. Mask ventilation will be maintained till complete muscle relaxation guided by a peripheral nerve stimulator. Using Macintosh laryngoscopy, an anesthetist who has at least three years experience and who will be blinded to the preoperative tests' results, determined the best laryngeal view by using Cormack-Lehane (CL) grading system from I-IV. External neck manipulation will be used when needed to obtain the best laryngoscopic view. Endotracheal intubation will then be accomplished. The number and duration of intubation attempts will be recorded.

Elderly

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

In our study, 150 elderly patients who are scheduled for elective surgeries under general anesthesia with endotracheal intubation accomplished using conventional laryngoscopy will be included.

You may qualify if:

  • elderly patients aged ≥ 65 years both male \& female .
  • ASA physical status I, II, and III .
  • patients scheduled for elective surgeries under general anesthesia .

You may not qualify if:

  • Patients undergoing emergency procedure
  • patients requiring elective awake fiberoptic.
  • patients having neuromuscular disorders or craniofacial abnormalities
  • patients with cervical spine surgeries, neck scars, obvious limited neck extension.
  • morbid obesity (MBI ˃40 kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine-Cairo University

Cairo, 1772, Egypt

Location

Related Publications (3)

  • Johnson KN, Botros DB, Groban L, Bryan YF. Anatomic and physiopathologic changes affecting the airway of the elderly patient: implications for geriatric-focused airway management. Clin Interv Aging. 2015 Dec 4;10:1925-34. doi: 10.2147/CIA.S93796. eCollection 2015.

    PMID: 26673904BACKGROUND
  • Etezadi F, Ahangari A, Shokri H, Najafi A, Khajavi MR, Daghigh M, Moharari RS. Thyromental height: a new clinical test for prediction of difficult laryngoscopy. Anesth Analg. 2013 Dec;117(6):1347-51. doi: 10.1213/ANE.0b013e3182a8c734.

    PMID: 24257384BACKGROUND
  • Prakash S, Mullick P, Bhandari S, Kumar A, Gogia AR, Singh R. Sternomental distance and sternomental displacement as predictors of difficult laryngoscopy and intubation in adult patients. Saudi J Anaesth. 2017 Jul-Sep;11(3):273-278. doi: 10.4103/1658-354X.206798.

    PMID: 28757825BACKGROUND

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Abeer Ahmed, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 10, 2022

Study Start

June 10, 2022

Primary Completion

August 20, 2022

Study Completion

September 10, 2022

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations