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

NCT ID: NCT06651879

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-20
• Study Completion Date: 2025-12-01

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.

Detailed Description

Unexpected difficult airway exposes the patient to serious morbidity and even mortality. Obstetrics airway carries the risk of complications due to physiological changes. The airway shows more restriction and changes in preeclamptic patients and peripartum periods. A study reported one incidence of difficult intubation in obstetrics in 20 cases. Inadequate airway management leads to failure in ventilation and oxygenation of the critically ill mother and her fetus.

the Practice Guidelines for Management of the Difficult Airway by the American Society of Anesthesiologists (ASA) define the difficult airway as difficult facemask ventilation of the upper airway, difficult tracheal intubation, or both. preoperative assessment of the airway avoids that risk; however, current clinical screening tests have low sensitivity and specificity with limited predictivity.

Ultrasound (US) provides a more precise assessment for tissues like epiglottis, vocal cords, and ring-shaped membranes; thus, it facilitates a bedside, non-invasive objective airway assessment. Moreover, ultrasound assessment can plan and guide airway interventions if needed. The airway in pregnancy goes through changes. a study concluded that The US airway assessment parameters differ significantly between pregnant and non-pregnant patients. Previous studies reported that the best predictors of difficult laryngoscopy and/or difficult intubation were the epiglottis midline-skin distance, hyoid bone-to-skin distance, thyroid cartilage-to-skin distance, thyrohyoid membrane-to-skin distance, and vocal cord anterior commissure-skin distance also predicted difficult airway. In Pregnancy, hyoid bone visibility, and Pre-E/E-VC ratio were independent predictors of the difficult airway.

Researchers suggested different techniques for airway ultrasound. Some suggested detailed technique that allows the determination of multiple parameters. Others suggested a more concise protocol to lessen the time of assessment and to avoid complexity.

This trial assesses 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 index (GREI) (9) in critically ill obstetric patients with pre-eclampsia.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Two views ultrasound technique

: 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

Group Type: EXPERIMENTAL

techniques of ultrasound examination of the airway

Intervention Type: DIAGNOSTIC_TEST

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

Five views ultrasound technique

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

Group Type: ACTIVE_COMPARATOR

techniques of ultrasound examination of the airway

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

techniques of ultrasound examination of the airway

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain shams university

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

wessam selima, MD

Role: CONTACT

w.z.selima@gmail.com

01001958858

ahmed moustafa, MD

Role: CONTACT

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

01121318459

Facility Contacts

Anesthesia department

Role: primary

anesth_office@med.asu.edu.eg

01009499962

References

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.

Reference Type: BACKGROUND

PMID: 34124099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31725624 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12411285 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36827944 (View on PubMed)

Other Identifiers

FMASU R147/2024

Identifier Type: -

Identifier Source: org_study_id