Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03547193
Other study ID # 2016-0405
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 5, 2017
Est. completion date August 30, 2017

Study information

Verified date May 2018
Source Università Politecnica delle Marche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Unpredictable laryngoscopic difficulty remains a dramatic challenge for anaesthesiologists. Ultrasound (US) based airway assessment has been recently proposed as a useful tool in adjunct to clinical methods, but to date few studies are available about the potential role of ultrasound in difficult airway evaluation.

The aim of this study is to determine the correlation between the sonographic measurements of anterior cervical soft tissues's thickness and Cormack-Lehane grade view at direct laryngoscopy in patients with normal clinical screening tests.

Design: Prospective, single blinded, observational study. Number of patients: 300 adult patients Methods: All patients are assessed before surgery to evaluate clinical evidence of difficult airways. Simultaneous ultrasound measures of the anterior cervical soft tissues are performed.

At induction of anaesthesia the laryngoscopic view is graded by a different anaesthetist, blinded to the ultrasound assessments.

Statistical analysis:

Receiver operating characteristic curves (ROC) are used to determine the "difficulty prediction capability" of each sonographic measurement and to assess the optimal cut-off scores To allow for comparisons between "restricted-difficult" airway and "easy" airway groups, a two-sided Student's t-test and Fisher's exact test is employed as appropriate. The results will be averaged (mean ± standard deviation SD) for each parameter for continuous data. Values of p < 0.05 are considered as statistically significant.


Description:

Unpredictable laryngoscopic difficulty, especially if difficult ventilation occurs, during standard laryngoscopy, remains a dramatic challenge for anaesthesiologists. Accurate airway assessment should always be performed, but the common clinical screening tests have shown low sensitivity and specificity with a limited predictive value. Ultrasound (US) based airway assessment has been recently proposed as a useful, simple, bedside and non-invasive tool in adjunct to clinical methods, but to date few studies are available about the potential role of ultrasound in difficult airway evaluation and these are mostly limited on specific groups of patients.

The aim of this prospective, single blinded, observational study is to determine the correlation between two neck ultrasound measures assessed at the pre-operative visit and Cormack-Lehane grade view at direct laryngoscopy, assessed at the induction of anaesthesia 24 hours later.

METHODS: During the pre-operative visit (24 hours before surgery), clinical screening tests to predict a difficult airway are performed and the anterior cervical soft tissue's thickness is assesses.

The thickness of the anterior cervical soft tissues is measured at two levels, thyro-hyoid membrane (pre-epiglottis space) and vocal cords (laryngeal inlet), using a US probe 10-13-MHz linear transducer placed in the transverse plane with the patient's head in neutral position.

On each level the distance from the skin in the median axis in cm (mDSE = median distance skin to epiglottis; mVC = median distance skin to vocal cords) and the surrounding Area in cm2 (PEA = pre-epiglottis area; AVC = Area pre vocal cords) are measured.

At the induction of anaesthesia the laryngoscopic view is graded by a different anaesthetist blinded to the ultrasound assessments and with more than 5 years of experience with OR activity. For each patient it's considered only the best attempt at direct laryngoscopy obtained after optimizing position, complete muscle relaxation (TOF=0), and, if necessary, external laryngeal manipulation. A decrease of SpO2 < 92% is a criterion for abandoning the procedure and a maximum of three attempts are admitted before declaring intubation failure with direct laryngoscopy. A Cormack-Lehane Grade 1 or 2a are classified as easy laryngoscopy and grade 2b - 3a - 3b or 4 as restricted or difficult laryngoscopy.

STATISTICAL ANALISYS: According to the literature, ultrasound measurements should predict as difficult at least 80% of the intubations that are really difficult (with a C-L ≥ 2b). Since the incidence of difficult intubation is about 5-10% of all intubations 1-3,6, it is necessary to study at least 244 patients in order to obtain statistically significant differences between the two groups accepting an alpha error of 0.05 and a beta error of 0.20.

Kolmogorov-Smirnov's test is used to test the normality of distribution. Receiver operating characteristic curves (ROC) is used to determine the "difficulty prediction capability" of each sonographic measurement and to assess the optimal cut-off scores To allow for comparisons between "restricted-difficult" airway and "easy" airway groups, a two-sided Student's t-test and Fisher's exact test are employed as appropriate. The results will be averaged (mean ± standard deviation SD) for each parameter for continuous data. Values of p < 0.05 were considered as statistically significant.

ETHICS: Ethical approval for this study was provided by Marche's Regional Ethics Committee (CERM), Ancona, ITA (Protocol No. 2016-0405); Chairperson: Prof Marcello D'Errico on 23 March 2017. Informed written consent was obtained. The study conformed to the Declaration of Helsinki and Good Clinical Practice guidelines.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date August 30, 2017
Est. primary completion date August 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients undergoing pre-operative evaluation for elective surgery

Exclusion Criteria:

- Predicted difficult intubation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy AOU Ospedali Riuniti Ancona - Università Politecnica delle Marche Ancona

Sponsors (1)

Lead Sponsor Collaborator
Università Politecnica delle Marche

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary median Distance Skin to Epiglottis (mDSE) The median Distance Skin to Epiglottis, unit of measure cm, is detected using a US linear probe (10-13-MHz) with the transducer placed in the transverse plane and the patient's head in neutral position. It represents the distance from the skin in the median axis and the epiglottis 24 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas