Obesity Difficult Airway Airway ManagementNCT06973434
Comparison of Video and Direct Laryngoscopy in Obese Patients During Surgery
An observational study of Obesity Difficult Airway Airway Management, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate how intubation performed with two different brands of videolaryngoscope and the Macintosh laryngoscope during surgeries in obese patients requiring general anesthesia affects the VIDIAC score, hemodynamic response, and early postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity Difficult Airway Airway Management
- What is being tested?
- intubation
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 20 Dec 2025
- 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
- Adult, Older adult
Study population: The study population will consist of adult patients between the ages of 18 and 65 years with a body mass index (BMI) of ≥30 kg/m², classified as American Society of Anesthesiologists (ASA) physical status I or II. All participants will be scheduled for elective surgery requiring general anesthesia and endotracheal intubation. Eligible participants must meet the inclusion criteria for obesity and provide written informed consent. Patients will be excluded if they have a known or anticipated difficult airway, advanced cardiopulmonary disease, pregnancy, coagulopathy, cervical spine movement limitation, or if they are scheduled for emergency surgery.
Who may be able to join
- Age between 18 and 65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I or II
- Scheduled for elective surgery
- Requiring endotracheal intubation
- Provided written informed consent
Who cannot join
- Refusal to participate in the study
- ASA physical status III, IV, or V
- Advanced cardiopulmonary disease
- Cervical spine movement limitation
- Pregnancy
- Coagulopathy
Show all 9Show fewer
- Emergency surgery indication
- Known or anticipated difficult airway
- Severe anatomical deformity of the airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effects of Conventional and Video Laryngoscopy Methods on VIDIAC Scores and Hemodynamic Stability in Obese Patients: Comparison of Storz C-MAC3, Scoper MAC-3 and Macintosh"
This study aims to evaluate how intubation performed with two different brands of videolaryngoscope and the Macintosh laryngoscope during surgeries in obese patients requiring general anesthesia affects the VIDIAC score, hemodynamic response, and early postoperative complications. Complications such as sore throat, hoarseness, nausea, and vomiting will be recorded in the recovery room prior to discharge.
Read the detailed description
Success in airway management is critical for the safety of anesthesia practices. Unsuccessful airway management is a leading cause of anesthesia-related morbidity-including airway trauma, dental injury, pulmonary aspiration, unplanned tracheostomy, hypoxic brain injury, and cardiopulmonary arrest-and mortality.
Unsuccessful airway management accounts for approximately 30-40% of anesthesia-related deaths. In a review of closed insurance claims against anesthesiologists, 17% were related to difficult or impossible intubation without documented preoperative airway assessment.
Video laryngoscopes are technological tools used to visualize airway structures and facilitate endotracheal intubation, particularly in patients with anticipated difficult airways.
Obesity is a metabolic disorder characterized by excessive fat accumulation and is associated with both physical and psychological complications. It is an independent risk factor for difficult airway and increases the risk of anesthesia-related complications. Obesity is also linked to restrictive lung disease due to increased intra-abdominal pressure and decreased thoracic compliance. The resulting reductions in static and dynamic lung volumes lead to rapid desaturation during apnea or hypoventilation, primarily due to reduced functional residual capacity and expiratory reserve volume.
In this prospective observational study, the investigators aim to perform a comparative analysis of VIDIAC scores, hemodynamic responses (heart rate, systolic and diastolic blood pressure, mean arterial pressure), and early postoperative complications following laryngoscopy performed with Storz C-MAC videolaryngoscope, Scoper videolaryngoscope, and Macintosh laryngoscope in obese patients undergoing elective surgery under general anesthesia.
- Being tested
- intubation
- Keywords
- Video laryngoscopy, Obesity, VIDIAC score, Storz C-MAC, Scoper MAC
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubationDevice
intubation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (n=40) Intubated with Storz C-MAC3 video laryngoscope | Participants in this group will be intubated using the Storz C-MAC3 video laryngoscope. Preoperative difficult intubation risk, and pre- and post-induction vital signs (heart rate, systolic and diastolic blood pressure, mean arterial pressure) will be recorded. Additionally, VIDIAC scores specific to video-assisted intubation and early postoperative intubation complications will be assessed for this group. Receives: Device: intubation | |
| Group 2 (n=40): Intubated with Scoper MAC-3 video laryngoscope | Participants in this group will be intubated using the Scoper MAC-3 video laryngoscope. Preoperative difficult intubation assessment, pre- and post-induction hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure), VIDIAC scoring for video laryngoscopy, and postoperative airway-related complications will be evaluated. Receives: Device: intubation | |
| Group 3 (n=40): Control group intubated with Macintosh laryngoscope | Participants in the control group will be intubated using a standard Macintosh direct laryngoscope. Their preoperative airway risk, vital signs before and after induction, and intubation-related complications will be recorded. VIDIAC score will not be used for this group as it applies only to video laryngoscopy. Receives: Device: intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VIDIAC (Video Intubation Difficulty Assessment and Classification) Score
Airway visualization will be assessed using the Video Intubation Difficulty Assessment and Classification (VIDIAC) scoring system during intubation. The VIDIAC score ranges from 1 to 5. A lower score indicates better visualization and easier intubation, while a higher score reflects increased difficulty. Score (1-5 scale)
Measured: Immediately after intubation (within 1 minute)
Heart Rate Change
Change in heart rate from baseline (pre-induction) to 5 minutes after intubation
Measured: Baseline to 5 minutes post-intubation
Secondary outcomes (2)
Successful First-Attempt Intubation Rate
Proportion of patients successfully intubated on the first attempt using the assigned laryngoscope device.laryngoscope.
Measured: Immediately after intubation (within 1 minute)
Intubation Time
Time measured in seconds from insertion of the laryngoscope blade to confirmation of successful endotracheal tube placement.
Measured: Immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 May 2025
- Primary completion30 Nov 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Difficult Airway Airway ManagementStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veli Fahri Pehlivan, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973434
- Sponsor's protocol ID
- Ümit
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of Conventional and Video Laryngoscopy Methods on VIDIAC Scores and Hemodynamic Stability in Obese Patients: Comparison of Storz C-MAC3, Scoper MAC-3 and Macintosh"
- ClinicalTrials.gov ID
- NCT06973434
- Acronym / sponsor ID
- Ümit
- Keywords
- Video laryngoscopy, Obesity, VIDIAC score, Storz C-MAC, Scoper MAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Harran UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 15 May 2025 (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.
This study aims to evaluate how intubation performed with two different brands of videolaryngoscope and the Macintosh laryngoscope during surgeries in obese patients requiring general anesthesia affects the VIDIAC score, hemodynamic response, and early postoperative complications. Complications such as sore throat, hoarseness, nausea, and vomiting will be recorded in the recovery room prior to discharge.
Detailed description
Success in airway management is critical for the safety of anesthesia practices. Unsuccessful airway management is a leading cause of anesthesia-related morbidity-including airway trauma, dental injury, pulmonary aspiration, unplanned tracheostomy, hypoxic brain injury, and cardiopulmonary arrest-and mortality.
Unsuccessful airway management accounts for approximately 30-40% of anesthesia-related deaths. In a review of closed insurance claims against anesthesiologists, 17% were related to difficult or impossible intubation without documented preoperative airway assessment.
Video laryngoscopes are technological tools used to visualize airway structures and facilitate endotracheal intubation, particularly in patients with anticipated difficult airways.
Obesity is a metabolic disorder characterized by excessive fat accumulation and is associated with both physical and psychological complications. It is an independent risk factor for difficult airway and increases the risk of anesthesia-related complications. Obesity is also linked to restrictive lung disease due to increased intra-abdominal pressure and decreased thoracic compliance. The resulting reductions in static and dynamic lung volumes lead to rapid desaturation during apnea or hypoventilation, primarily due to reduced functional residual capacity and expiratory reserve volume.
In this prospective observational study, the investigators aim to perform a comparative analysis of VIDIAC scores, hemodynamic responses (heart rate, systolic and diastolic blood pressure, mean arterial pressure), and early postoperative complications following laryngoscopy performed with Storz C-MAC videolaryngoscope, Scoper videolaryngoscope, and Macintosh laryngoscope in obese patients undergoing elective surgery under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (n=40) Intubated with Storz C-MAC3 video laryngoscope | – | Device: intubationParticipants in this group will be intubated using the Storz C-MAC3 video laryngoscope. Preoperative difficult intubation risk, and pre- and post-induction vital signs (heart rate, systolic and diastolic blood pressure, mean arterial pressure) will be recorded. Additionally, VIDIAC scores specific to video-assisted intubation and early postoperative intubation complications will be assessed for this group. |
| Group 2 (n=40): Intubated with Scoper MAC-3 video laryngoscope | – | Device: intubationParticipants in this group will be intubated using the Scoper MAC-3 video laryngoscope. Preoperative difficult intubation assessment, pre- and post-induction hemodynamic parameters (heart rate, systolic and diastolic blood pressure, mean arterial pressure), VIDIAC scoring for video laryngoscopy, and postoperative airway-related complications will be evaluated. |
| Group 3 (n=40): Control group intubated with Macintosh laryngoscope | – | Device: intubationParticipants in the control group will be intubated using a standard Macintosh direct laryngoscope. Their preoperative airway risk, vital signs before and after induction, and intubation-related complications will be recorded. VIDIAC score will not be used for this group as it applies only to video laryngoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients between the ages of 18 and 65 years with a body mass index (BMI) of ≥30 kg/m², classified as American Society of Anesthesiologists (ASA) physical status I or II. All participants will be scheduled for elective surgery requiring general anesthesia and endotracheal intubation. Eligible participants must meet the inclusion criteria for obesity and provide written informed consent. Patients will be excluded if they have a known or anticipated difficult airway, advanced cardiopulmonary disease, pregnancy, coagulopathy, cervical spine movement limitation, or if they are scheduled for emergency surgery.
Key inclusion criteria (6 listed)
- Age between 18 and 65 years
- Body mass index (BMI) ≥30 kg/m²
- ASA physical status I or II
- Scheduled for elective surgery
- Requiring endotracheal intubation
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- ASA physical status III, IV, or V
- Advanced cardiopulmonary disease
- Cervical spine movement limitation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intubationintubation | Device | Group 1 (n=40) Intubated with Storz C-MAC3 video laryngoscope, Group 2 (n=40): Intubated with Scoper MAC-3 video laryngoscope, Group 3 (n=40): Control group intubated with Macintosh laryngoscope |
Primary outcome
VIDIAC (Video Intubation Difficulty Assessment and Classification) Score
Time frame: Immediately after intubation (within 1 minute)
Airway visualization will be assessed using the Video Intubation Difficulty Assessment and Classification (VIDIAC) scoring system during intubation. The VIDIAC score ranges from 1 to 5. A lower score indicates better visualization and easier intubation, while a higher score reflects increased difficulty. Score (1-5 scale)
Heart Rate Change
Time frame: Baseline to 5 minutes post-intubation
Change in heart rate from baseline (pre-induction) to 5 minutes after intubation
2 secondary outcomes
Successful First-Attempt Intubation Rate
Time frame: Immediately after intubation (within 1 minute)
Intubation Time
Time frame: Immediately after intubation
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity Difficult Airway Airway Management, run by Harran 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 6 inclusion and 9 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 27 Feb 2026. 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?
VIDIAC (Video Intubation Difficulty Assessment and Classification) Score (time frame: Immediately after intubation (within 1 minute)). 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 27 Feb 2026.