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Intubation;DifficultNCT04542187

Pre-Operative Airway Assessment of Patients With Morbid Obesity

An observational study of Intubation;Difficult and Obesity, Morbid, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Backround:The incidence of difficulty in laryngoscopy and endotracheal intubation is more common in obese patients. There are conflicting data on factors predicting difficult intubation. Also, these predictors are uncertain when video laryngoscopy (VL) is used. Read more about this study

Who is it for?
Ages 16 to 68 years
Conditions the study is for
Intubation;Difficult, Obesity, Morbid
How many people
121 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2019to 1 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 68 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: After obtaining the patients written informed consent, as a result of the power analysis, one hundred and twenty-one patients, aged 16-68 years, with a BMI ≥ 45 kg/m2, who were undergoing elective bariatric surgery were included in this study. Patients with a history of difficult airway, limited neck movements, oral-pharyngeal cancer or reconstructive surgery, cervical spinal injury and facial anomaly or scar, patients who required quick and awake endotracheal intubation, and patients who were not oriented-cooperative, were excluded from the study.

Who may be able to join

  • Patients with a BMI ≥ 45 kg/m2
  • Patients undergoing bariatric surgery

Who cannot join

  • Patients with a history of difficult airway
  • Patients with a limited neck movements
  • Patients with a cervical spinal injury
  • Patients with a facial anomaly or scar
  • Patients who required quick and awake endotracheal intubation
  • Patients who were not oriented-cooperative

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bagcilar Training and Research Hospital

    Istanbul, 34200

Other trials in Turkey (Türkiye)

About this study

Official title: Correlation Between Pre-Operative Airway Assessment Tests, Anthropometric Measurements And The Video-Laryngoscopic Modified Cormack-Lehane Visualization and Their Predictive Values for Difficult Intubation in Obesity Class-III Patients

Backround:The incidence of difficulty in laryngoscopy and endotracheal intubation is more common in obese patients. There are conflicting data on factors predicting difficult intubation. Also, these predictors are uncertain when video laryngoscopy (VL) is used. In this study we aim to investigate the correlation between airway assessment tests, anthropometric measurements and Modified Cormack-Lehane Classification (MCLC), assessed by C-MAC-D-blade VL and predictive values for intubation difficulty in class-III patients.

Methods: This prospective observational study was performed in 121 obese patients (Body mass index (BMI)≥45kg/m2) undergoing bariatric surgery. BMI, modified mallampati scores (MMS), thyromental distance (TMD), sternomental distance (SMD), interincisor distance (IID), and neck, waist, and chest circumference were all recorded preoperatively. Endotracheal intubations were performed with a C-MAC D-blade VL. The glottic view and intubation difficulty were determined according to the MCLC. MCLC I-IIa was recorded as the group with no risk of a difficult intubation, the MCLC IIb-III was recorded as the group with risk of a difficult intubation and the MCLC-IV was recorded as the group with a difficult intubation. The correlation between the airway tests, anthropometric parameters and the MCLC, as well as their sensitivity and specificity in predicting the intubation difficulty based on the MCLC, were analyzed. The duration of intubation, number of attempts, external laryngeal maneuver, the equipment requirements (style, guide), and complications during intubation were recorded.

Read the detailed description

Study Design This prospective observational clinical study was conducted in patients with a BMI ≥ 45 kg/m2 undergoing elective bariatric surgery between January 2018 and January 2019, in the Anesthesiology and Reanimation Clinic of the Health Sciences University, Bagcilar Training and Research Center, after obtaining approval from the Ethics Board of Health Sciences University Istanbul Bagcilar Training and Research Hospital (17.08.2017-2017/599).

Patient population The number of participants in this study was calculated based upon a previous study. A sample size calculator showed that 116 participants would be required to predict difficult intubation in obese patients (with 80% power, α=0,05 and, β=0,2). After obtaining the patients written informed consent, as a result of the power analysis, one hundred and twenty-one patients, aged 16-68 years, with a BMI ≥ 45 kg/m2, who were undergoing elective bariatric surgery were included in this study. Patients with a history of difficult airway, limited neck movements, oral-pharyngeal cancer or reconstructive surgery, cervical spinal injury and facial anomaly or scar, patients who required quick and awake endotracheal intubation, and patients who were not oriented-cooperative, were excluded from the study.

Study Protocol Age, sex, height, body weight, BMI, airway assessments and anthropometric measurements, including the MMS, thyromental distance TMD), sternomental distance (SMD), interincisor distance (IID), and neck, waist and chest circumference measurements of all patients were evaluated and recorded preoperatively. The MMS was assessed by Samsoon and Young Modifications and scores were assessed 1 to 4. The TMD and SMD were measured with the neck fully extended. The TMD was measured between the upper border of the thyroid cartilage and the bony point of the mentum, and the SMD was measured between the upper border of the manubrium sterni and the bony point of the mentum. The IID was measured when the patient opened their mouth, and the distance between upper and lower incisors was obtained. Neck circumference was measured at the level of the thyroid cartilage when the head was in a neutral position. The chest and waist circumference was measured around the widest circumference.

After patients were admitted to the operating room, all patients were positioned with the gel placed under their head. The intravenous route was inserted in the dorsum of the hand using a 20 G (Gauge) venous cannula, and a 2-4 mL/kg balanced crystalloid was infused. All patients were premedicated with 1-2mg midazolam (Zolamid 15mg/3ml, Defarma, Turkey). Each patient was routinely monitored with the standard monitorization, including three-lead electrocardiography (ECG), non-invasive arterial pressure, peripheral oxygen saturation (SpO2), and neuromuscular monitorization with the TOF-Watch SX (Organon, Ireland) device. All patients were pre-oxygenated using a face mask, with 100% oxygen for 3 to 5 minutes prior to induction of the anesthesia. Induction is made with 2 mg/kg propofol (Propofol 1%, Fresenius kabi, Germany) and 1 µgr/kg fentanyl (Talinat, VEM, Turkey) based on a lean body weight, and 0.6 mg /kg rocuronium bromide (Esmeron Organon, Holland) based on an ideal body weight. Following the adequate paralysis (loss of responsiveness to train of four stimulations with TOF), all patients were routinely intubated using C-MAC D-blade VL (Storz 8402 ZX C- MAC Karl Storz, Germany). Anesthesia was maintained with inhalation of 50% oxygen-medical air mixture and 2% minimum alveolar concentration (MAC) of sevoflurane (Sevoflurane, Abbott, England).

The time of the tracheal intubation was defined from insertion of the VL in the mouth until the endotracheal tube was placed through the vocal cords and expired carbon dioxide at capnography was observed. In the case of a peripheral oxygen saturation decrease (< 90%), performing of intubation was interrupted, and mask ventilation was resumed.

As there is no validated classification for the glottic view with VL intubation, it was evaluated and recorded according to the MCLC modified by Yentis and Lee, without any laryngeal pressure as shown below.

MCLC I: A full view of the glottis MCLC IIa: Partial view of the glottis is visible MCLC IIb: Arytenoids or posterior part of the vocal cords are only just visible MCLC III: Only the epiglottis is visible MCLC IV: Neither epiglottis nor the glottis are visible MCLC I-IIa was recorded as the group with no risk of a difficult intubation, MCLC IIb-III was recorded as the group with a risk of a difficult intubation, the grade MCLC IIb was associated with a greater difficulty for intubation with a grade III, and MCLC-IV was recorded as the group with difficult intubation. The time of intubation, number of attempts, external laryngeal maneuver, stylet or both the usage requirements and complications (airway trauma, soft tissue hemorrhage, tooth damage, etc.) were recorded.

All airway assessment tests, and anthropometric parameters were performed by the same anesthesiologist. All the endotracheal intubations and assessment of MCLC were routinely performed with a C-MAC D-blade VL by another anesthesiologist who was blinded to the datas of the preoperatively assessed tests.

Primary and Secondary Outcomes The primary outcomes were the correlation between the preoperative airway assessment tests (MMS, TMD, SMD, IID), anthropometric measurements (BMI, neck, waist, chest circumference), and MCLC assessed by VL as well as their predictive values for the intubation difficulty according to the MCLC. Secondary outcomes were the time for intubation, number of attempts, equipment (stylet) and external laryngeal maneuver (ELM) requirements, as well as the complications during intubation (lip trauma, soft tissue hemorrhage, tooth damage, supraglottic trauma, etc.).

Statistical Methods Statistical analyses were performed using SPSS Statistics 21 Statistical Package for the Social Sciences (SPSS Inc, Chicago, IL, USA). Continuous variables are expressed as means and standard deviation. The Kolmogrov-Smirnov test was used to investigate the normal distribution of continuous data. The Student's test was used for normally distributed continuous variables. The Mann-Whitney U test was used for variables that were not normally distributed. The Chi-Square and Fisher's Exact tests were used for non-continuous variables. To evaluate the change of continuous variables both Pearson correlation analysis was used for parametric data and Spearman Correlation analysis was used for nonparametric data. The evaluation of correlation coefficient; r=0.00-0.24, r=0.25-0.49, r=0.50-0.74, r=0.75-1.00 were considered as weak, moderate, strong and very strong respectively. The cut-off points for statistically significant parameters were determined by using the receiver operating curve (ROC) analysis which resulted in the best combination for sensitivity and specificity. Sensitivity, specificity, positive predictive and negative predictive values were calculated in the presence of significant limit values. All variables at p < 0.05 were considered as statistically significant.

Keywords
Intubation, airway evaluation, obesity, videolaryngoscopy
Medical subject headings
Obesity, Morbid, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of attempts for intubation

    Number of attempts required to perform successful intubation

    Measured: 6 months

  2. Modified Cormack-Lehane classification

    It will be evaluated with videolarengoscopy

    Measured: 6 months

Secondary outcomes (1)
  1. Time needed for intubation

    Time from insertion of laryngoscope into the mouth to the endotracheal intubation

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Jul 2019
  4. Study completion1 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542187
Sponsor's protocol ID
2017/599
Status last verified
Sep 2020
First submitted
27 Aug 2020
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We can share all protocol with other researchers.

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation;Difficult and Obesity, Morbid, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of attempts for intubation (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

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