Ultrasound Airway Assessment of Critically Ill Preeclamptic; Comparison Between Two Technique

NCT06651879 | Recruiting

• 1 other identifier: FMASU R147/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Unexpected difficult airway exposes the patient to serious morbidity and even mortality. The changes in pregnancy and preeclampsia increase the risk of difficult intubation. Proper anticipation affects the outcome and enhances safety, especially in critically ill patients. This research aims to assess the superiority of either 2 views or 5 views ultrasound assessment in predictivity of difficult airway (difficult ventilation, laryngoscopy, and intubation) and their comparison to traditional clinical examination by El-Ganzouri Risk Index (EGRI) in critically ill obstetric patients with pre-eclampsia.

Conditions

Critical Illness; Difficult; Intubation, Postpartum, During Puerperium; Pre-Eclampsia

Outcome Measures

Primary Outcomes (2)

• The predictivity of both us techniques in relation to clinical assessment of El-Ganzouri index (EGRI).

  Sensitivity and specificity of the measured parameters in both ultrasound techniques in relation to the clinical El-ganzouri score where (score \< 4 is unlikely to be difficult and score ≥ 4 is more likely to be difficult) to predict difficult airway.

  the degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, clinical assessment will be preoperative, the us assessment will be preoperative at the same day of operation or immediately postoperative

• The predictive superiority between 2 view and 5 views ultrasound techniques regarding difficult ventilation, laryngoscopy and intubation

  * Difficult ventilation is measured by Hans score where grade 0 and 1 will be categorized as easy ventilation, while \<= 2 are difficult * Difficult intubation is measured by Cormack-Lehane grade where where grade 1 nad 2a will be categorized as easy while \<= 2b will be categorized as difficult. * Prolonged intubation \<10 min or repeated attempts \< 3 will be categorized as difficult.

  the actual degree of difficult intubation will be assesed intraoperative after aneesthesia and intubation, the us assessment will be done preoperative at the same day of operation or immediately postoperative

Secondary Outcomes (2)

• postoperative side effects

  within 24 hours postoperative

• duration of the airway assessment

  preoperative

Study Arms (2)

Two views ultrasound technique

EXPERIMENTAL

: the ultrasound examiner will use the difficult airway examination by sonography (DARES) protocol in which involves only two views of the upper airway: the thyrohyoid and the suprahyoid views. Measurements selected for this protocol include the DSE, HMD, HMDR1, HMDR2, and tongue thickness, which cover all three domains of TTD, APD, and OSD

Diagnostic Test: techniques of ultrasound examination of the airway

Five views ultrasound technique

ACTIVE COMPARATOR

The thicknesses of the anterior neck soft tissues will be measured by systematic examination includes five views: 1) Suprahyoid View .2) Thyrohyoid view; will be used to visualize epiglottis and pre -epiglottic space(PES).3) Thyroid view; for vocal cord visualization.4) Cricothyroid view .5) Suprasternal view From the previous views the following will be measured: tongue volume (TV ) ANS-H: anterior neck skin thickness at hyoid; TMD: thyromental distance; ANS-E: anterior neck skin thickness at epiglottis; ANS-VC: anterior neck skin thickness at vocal cords; SD: subglottic diameter PreE: pre epiglottic space; aVF: anterior vocal folds; pVF: posterior vocal folds; mVF: midpoint of anterior , posterior vocal folds , and diameter of the transverse tracheal air shadow in the subglottic area . The following will be calculated PreE/aVF, PreE/mVF , PreE/pVF and PreE/E-VC. That will be in addition to detection of any abnormalities in the airway

Diagnostic Test: techniques of ultrasound examination of the airway

Interventions

techniques of ultrasound examination of the airway DIAGNOSTIC_TEST

two different techniques of ultrasound. The techniques are the two views and the five views

Five views ultrasound technique; Two views ultrasound technique

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 60 years.
• Singleton or multiple pregnancies,
• Mentally competent.
• American Society of Anesthesiologists (ASA) physical status I, II and III

You may not qualify if:

• Patient's Refusal to participate,
• Abnormal pharynx or airway anatomy,
• expected difficult laryngoscopy with cervical spine abnormality,
• Maxillofacial anomalies,
• upper airway diseases or malignancy,
• Unconscious women,
• those with learning difficulties, or mentally handicapped

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Cairo Governorate, 11528, Egypt

RECRUITING

Related Publications (4)

• Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.

  PMID: 34124099 BACKGROUND

• Zheng BX, Zheng H, Lin XM. Ultrasound for predicting difficult airway in obstetric anesthesia: Protocol and methods for a prospective observational clinical study. Medicine (Baltimore). 2019 Nov;98(46):e17846. doi: 10.1097/MD.0000000000017846.

  PMID: 31725624 BACKGROUND

• Izci B, Riha RL, Martin SE, Vennelle M, Liston WA, Dundas KC, Calder AA, Douglas NJ. The upper airway in pregnancy and pre-eclampsia. Am J Respir Crit Care Med. 2003 Jan 15;167(2):137-40. doi: 10.1164/rccm.200206-590OC. Epub 2002 Oct 31.

  PMID: 12411285 BACKGROUND

• Bala R, Budhwar D, Kumar V, Singhal S, Kaushik P, Sharma J. Clinical and ultrasonographic assessment of airway indices among non-pregnant, normotensive pregnant and pre-eclamptic patients: a prospective observational study. Int J Obstet Anesth. 2023 May;54:103637. doi: 10.1016/j.ijoa.2023.103637. Epub 2023 Feb 1.

  PMID: 36827944 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

wessam selima, MD

CONTACT

01001958858; w.z.selima@gmail.com

ahmed moustafa, MD

CONTACT

01121318459; drahmed.mostafa.mohamed@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: both care providers are blinded: the ultrasound examiner will be blinded regarding the clinical evaluation of the airway. the anesthesiologist will be blinded regarding the ultrasound airway assessment
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is a pilot of randomized clinical, two parallel groups, 1:1 allocation, superiority study.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: October 22, 2024
• Study Start: July 20, 2024
• Primary Completion: November 20, 2025
• Study Completion: December 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-01

Locations

EG (1)