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).
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
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.
- Conditions
- Intubation;Difficult, Obesity, Morbid
- 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.
Number of attempts for intubation
Number of attempts required to perform successful intubation
Measured: 6 months
Modified Cormack-Lehane classification
It will be evaluated with videolarengoscopy
Measured: 6 months
Secondary outcomes (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.
- First posted9 Sep 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Serdar Demirgan, MD, Principal investigator, Health Science University Bağcılar Training and Research Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04542187
- Acronym / sponsor ID
- 2017/599
- Conditions
- Intubation;Difficult, Obesity, Morbid
- Keywords
- Intubation, airway evaluation, obesity, videolaryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Patients with a BMI ≥ 45 kg/m2
- Patients undergoing bariatric surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of attempts for intubation
Time frame: 6 months
Number of attempts required to perform successful intubation
Modified Cormack-Lehane classification
Time frame: 6 months
It will be evaluated with videolarengoscopy
1 secondary outcome
Time needed for intubation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Yes. We can share all protocol with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar Demirgan, MD principal investigator
Health Science University Bağcılar Training and Research Hospital
1 site in 1 country: see every site and its status.
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.