Morbid ObesityNCT02589015
Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients
An observational study of Morbid Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2015to Dec 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with body mass index (BMI) > = 40, applied for elective surgery.
Who may be able to join
- BMI >= 40
- American Society of Anesthesiologists (ASA) Physical Status I-III
- Patients applied for elective surgery
Who cannot join
- BMI < 40
- maxillofacial tumor or fracture
- mass at the neck
- mass in the thorax or mediastina
- scar at the neck area
- previous radiotherapy history to neck area
- history of cervical vertebra operations
- cervical vertebra structure abnormality
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098
About this study
Official title: Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Turkish Patients: A Prospective Clinical Trial
The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.
Read the detailed description
Patients' Mallampati score, upper lip bite test, neck mobility, teeth abnormalities were evaluated preoperatively. Mouth opening, sternomental and thyromental distances, neck circumference, thoracic circumference, breast circumference , belly circumference and hip circumference were measured preoperatively.
After anesthesia induciton with propofol and rocuronium, patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Laringoscopy was performed with MacIntosh laryngoscop and Cormack Lehane (CL) score was evaluated. CL score III and IV were defined as difficult laryngoscopy.
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, neck circumference, difficult mask ventilation, difficult laryngoscopy
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of difficult laryngoscopy with neck circumference
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with neck circumference
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Secondary outcomes (20)
Correlation of difficult laryngoscopy with modified mallampati score
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with modified mallampati score
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed after during mask ventilation
Correlation of difficult laryngoscopy with neck movement
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
Measured: Cormack Lehane score was assessed during laryngoscopy
with neck movement
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with dentition
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with dentition
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with upper lip bite test
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with upper lip bite test
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with mouth opening
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with mouth opening
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with sternomental distance
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with sternomental distance
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with breast circumference
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with breast circumference
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with thorax circumference
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with thorax circumference
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with waist circumference
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with waist circumference
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with hip circumference
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
Measured: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with hip circumference
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Measured: Ventilation difficulty scale was assessed during mask ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ozdilek, Istanbul University
- Investigators
- Güniz Köksal, Professor, Study director, Istanbul University Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589015
- Sponsor's protocol ID
- 02-887/2
- Status last verified
- Feb 2016
- First submitted
- 20 Aug 2015
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ozdilek A, Beyoglu CA, Erbabacan SE, Ekici B, Altindas F, Vehid S, Koksal GM. Correlation of Neck Circumference with Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients: an Observational Study. Obes Surg. 2018 Sep;28(9):2860-2867. doi: 10.1007/s11695-018-3263-3.
PubMed 29687341
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Turkish Patients: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02589015
- Acronym / sponsor ID
- 02-887/2
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, neck circumference, difficult mask ventilation, difficult laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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.
The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.
Detailed description
Patients' Mallampati score, upper lip bite test, neck mobility, teeth abnormalities were evaluated preoperatively. Mouth opening, sternomental and thyromental distances, neck circumference, thoracic circumference, breast circumference , belly circumference and hip circumference were measured preoperatively.
After anesthesia induciton with propofol and rocuronium, patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
Laringoscopy was performed with MacIntosh laryngoscop and Cormack Lehane (CL) score was evaluated. CL score III and IV were defined as difficult laryngoscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with body mass index (BMI) > = 40, applied for elective surgery.
Key inclusion criteria (3 listed)
- BMI >= 40
- American Society of Anesthesiologists (ASA) Physical Status I-III
- Patients applied for elective surgery
Key exclusion criteria (8 listed)
- BMI < 40
- maxillofacial tumor or fracture
- mass at the neck
- mass in the thorax or mediastina
- scar at the neck area
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
Correlation of difficult laryngoscopy with neck circumference
Time frame: Cormack Lehane score was assessed during laryngoscopy
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
Correlation of difficult mask ventilation with neck circumference
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.
20 secondary outcomes
Correlation of difficult laryngoscopy with modified mallampati score
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with modified mallampati score
Time frame: Ventilation difficulty scale was assessed after during mask ventilation
Correlation of difficult laryngoscopy with neck movement
Time frame: Cormack Lehane score was assessed during laryngoscopy
with neck movement
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with dentition
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with dentition
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with upper lip bite test
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with upper lip bite test
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with mouth opening
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with mouth opening
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with sternomental distance
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with sternomental distance
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with breast circumference
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with breast circumference
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with thorax circumference
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with thorax circumference
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with waist circumference
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with waist circumference
Time frame: Ventilation difficulty scale was assessed during mask ventilation
Correlation of difficult laryngoscopy with hip circumference
Time frame: Cormack Lehane score was assessed during laryngoscopy
Correlation of difficult mask ventilation with hip circumference
Time frame: Ventilation difficulty scale was assessed during mask ventilation
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 11 Feb 2016.
- Derived from this study: PubMed 29687341Ozdilek A, Beyoglu CA, Erbabacan SE, Ekici B, Altindas F, Vehid S, Koksal GM. Correlation of Neck Circumference with Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients: an Observational Study. Obes Surg. 2018 Sep;28(9):2860-2867. doi: 10.1007/s11695-018-3263-3.
- Individual participant dataSharing planned: Undecided
Related trials for Morbid Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
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.
Güniz Köksal, Professor study director
Istanbul University Cerrahpasa Medical Faculty
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 Morbid Obesity, run by Istanbul University 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 3 inclusion and 8 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 11 Feb 2016. 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?
Correlation of difficult laryngoscopy with neck circumference (time frame: Cormack Lehane score was assessed during laryngoscopy). 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?
On the ClinicalTrials.gov record for NCT02589015, which also lists 1 linked publication.
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 11 Feb 2016.