AcromegalyACRO-VLNCT07659912
Direct Versus Video Laryngoscopy in Patients With Acromegaly
An observational study of Acromegaly and Nonfunctioning Pituitary Adenoma, run by Muzaffer GENCER.
Trial summary
Acromegaly is associated with craniofacial skeletal changes and upper airway soft tissue hypertrophy, which may increase the risk of difficult laryngoscopy and tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly, Nonfunctioning Pituitary Adenoma
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with acromegaly or nonfunctioning pituitary adenoma who are evaluated by the institutional pituitary diseases council and scheduled for elective surgery under general anesthesia requiring endotracheal intubation at Basaksehir Cam and Sakura City Hospital.
Who may be able to join
- Age 18 years or older
- Diagnosis of acromegaly and scheduled for surgery after evaluation by the institutional pituitary diseases council
- Diagnosis of nonfunctioning pituitary adenoma and scheduled for surgery after evaluation by the institutional pituitary diseases council
- Requirement for general anesthesia with endotracheal intubation
- Ability and willingness to provide written informed consent
Who cannot join
- Age younger than 18 years
- Refusal to participate in the study
- Presence of extrapituitary malignancy
- Emergency surgery
- Previous tracheostomy or major laryngeal/tracheal surgery
- Severe limitation of mouth opening preventing standard laryngoscopic evaluation
Show all 9Show fewer
- Cervical spine instability or severe restriction of neck extension
- Patients requiring awake fiberoptic intubation according to preoperative airway assessment
- Patients for whom participation is considered unsafe by the responsible anesthesiologist
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Determination of the Appropriate Intubation Method in Patients With Acromegaly: Comparison of Direct Laryngoscopy and Video Laryngoscopy
Acromegaly is associated with craniofacial skeletal changes and upper airway soft tissue hypertrophy, which may increase the risk of difficult laryngoscopy and tracheal intubation. This prospective observational study aims to evaluate airway and intubation characteristics in patients with acromegaly undergoing surgery under general anesthesia and to compare direct laryngoscopy and video laryngoscopy findings.
Adult patients with acromegaly and patients with nonfunctioning pituitary adenomas scheduled for surgery under general anesthesia will be prospectively enrolled between July 1, 2026, and August 31, 2026. Preoperative airway assessment parameters, hormonal data including growth hormone and insulin-like growth factor-1 levels, Mallampati score, modified Cormack-Lehane grade, intubation-related variables, and peri-intubation complications will be recorded.
Read the detailed description
This prospective observational study will be conducted at Basaksehir Cam and Sakura City Hospital between July 1, 2026, and August 31, 2026. The study population will include adult patients with acromegaly and adult patients with nonfunctioning pituitary adenomas who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Eligible patients will undergo routine preoperative airway assessment. Recorded variables will include age, sex, height, body weight, body mass index, history of obstructive sleep apnea syndrome, comorbid diseases, previous operations, presence of hypopituitarism, preoperative growth hormone level, preoperative insulin-like growth factor-1 level, IGF-1 index, Mallampati score, and other airway-related clinical parameters.
During airway management, laryngoscopic findings obtained with direct laryngoscopy and video laryngoscopy will be recorded. The modified Cormack-Lehane classification will be used to assess glottic visualization. Intubation-related variables, including first-attempt success, time to successful intubation, number of intubation attempts, need for adjunct airway maneuvers or devices, oxygen desaturation, and airway trauma, will also be documented.
The primary objective of the study is to compare laryngoscopic findings and intubation characteristics in patients with acromegaly and to evaluate whether video laryngoscopy provides advantages over direct laryngoscopy in this patient group. The secondary objective is to identify clinical, hormonal, and airway-related predictors of difficult laryngoscopy or difficult intubation in patients with acromegaly.
- Conditions
- Acromegaly, Nonfunctioning Pituitary Adenoma
- Keywords
- Acromegaly, Difficult Intubation, Direct Laryngoscopy, Video Laryngoscopy, Cormack-Lehane Classification, Airway Management, Growth Hormone, Insulin-Like Growth Factor 1, Pituitary Adenoma
- Medical subject headings
- Acromegaly, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acromegaly Group | Adult patients diagnosed with acromegaly who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation. | |
| Nonfunctioning Pituitary Adenoma Group | Adult patients diagnosed with nonfunctioning pituitary adenoma who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy
The modified Cormack-Lehane grade obtained during direct laryngoscopy and video laryngoscopy will be recorded and compared to evaluate glottic visualization and the degree of laryngoscopic difficulty.
Measured: During tracheal intubation procedure
Secondary outcomes (8)
Mallampati Classification Score
The preoperative Mallampati Classification score will be recorded as part of the routine airway assessment and evaluated for its association with difficult laryngoscopy or difficult intubation. The Mallampati Classification ranges from Class I to Class IV, with a minimum value of Class I and a maximum value of Class IV. Higher scores indicate poorer visualization of the oropharyngeal structures and a worse airway assessment, reflecting a greater likelihood of difficult laryngoscopy or difficult intubation.
Measured: Preoperative airway assessment before induction of anesthesia
Time to Successful Intubation
Time to successful intubation will be defined as the time, measured in seconds, from insertion of the laryngoscope into the oral cavity to confirmation of endotracheal tube placement by capnography.
Measured: During tracheal intubation procedure
Number of Intubation Attempts
The total number of laryngoscopy attempts required for successful endotracheal intubation will be recorded. An intubation attempt will be defined as each insertion of the laryngoscope into the oral cavity with the intention of endotracheal tube placement.
Measured: During tracheal intubation procedure
Need for Adjunct Airway Maneuvers or Devices
The need for adjunct airway maneuvers or devices will be recorded as a binary outcome, defined as whether any additional airway maneuver or device is required to achieve successful endotracheal intubation. Adjuncts may include external laryngeal manipulation, stylet, bougie, change of laryngoscope, supraglottic airway device, or fiberoptic bronchoscopy.
Measured: From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure
Peri-Intubation Oxygen Desaturation
Peri-intubation oxygen desaturation will be defined as a decrease in peripheral oxygen saturation below 90% during airway management.
Measured: From anesthesia induction to 5 minutes after intubation
Airway Trauma
Airway trauma will be assessed by the presence of mucosal bleeding, dental trauma, lip injury, or other visible airway-related injury after intubation.
Measured: Immediately after intubation
Association Between Growth Hormone Level and Difficult Laryngoscopy
Preoperative growth hormone levels will be recorded and analyzed for their association with the modified Cormack-Lehane grade and difficult laryngoscopy. Difficult laryngoscopy will be assessed during tracheal intubation based on the modified Cormack-Lehane grade.
Measured: Baseline preoperative assessment and during the tracheal intubation procedure
Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy
Preoperative insulin-like growth factor 1 levels and insulin-like growth factor 1 index will be recorded and analyzed for their association with the modified Cormack-Lehane grade and difficult laryngoscopy. Difficult laryngoscopy will be assessed during tracheal intubation based on the modified Cormack-Lehane grade.
Measured: Preoperative baseline assessment and during the tracheal intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muzaffer GENCER
- Sponsor type
- Other government
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor-investigator, Muzaffer GENCER, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659912
- Sponsor's protocol ID
- ACRO-VL-2026
- Acronym
- ACRO-VL
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Only aggregated and anonymized study results may be presented in scientific meetings or published in peer-reviewed journals.
Publications
Friedel ME, Johnston DR, Singhal S, Al Khalili K, Farrell CJ, Evans JJ, Nyquist GG, Rosen MR. Airway management and perioperative concerns in acromegaly patients undergoing endoscopic transsphenoidal surgery for pituitary tumors. Otolaryngol Head Neck Surg. 2013 Dec;149(6):840-4. doi: 10.1177/0194599813507236. Epub 2013 Oct 3.
PubMed 24091425Ali Z, Bithal PK, Prabhakar H, Rath GP, Dash HH. An assessment of the predictors of difficult intubation in patients with acromegaly. J Clin Neurosci. 2009 Aug;16(8):1043-5. doi: 10.1016/j.jocn.2008.11.002. Epub 2009 May 19.
PubMed 19457671Zhang Y, Guo X, Pei L, Zhang Z, Tan G, Xing B. High levels of IGF-1 predict difficult intubation of patients with acromegaly. Endocrine. 2017 Aug;57(2):326-334. doi: 10.1007/s12020-017-1338-x. Epub 2017 Jun 15.
PubMed 28620866
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Appropriate Intubation Method in Patients With Acromegaly: Comparison of Direct Laryngoscopy and Video Laryngoscopy
- ClinicalTrials.gov ID
- NCT07659912
- Acronym / sponsor ID
- ACRO-VL / ACRO-VL-2026
- Conditions
- Acromegaly, Nonfunctioning Pituitary Adenoma
- Keywords
- Acromegaly, Difficult Intubation, Direct Laryngoscopy, Video Laryngoscopy, Cormack-Lehane Classification, Airway Management, Growth Hormone, Insulin-Like Growth Factor 1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Muzaffer GENCEROther government
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Jun 2026 (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.
Acromegaly is associated with craniofacial skeletal changes and upper airway soft tissue hypertrophy, which may increase the risk of difficult laryngoscopy and tracheal intubation. This prospective observational study aims to evaluate airway and intubation characteristics in patients with acromegaly undergoing surgery under general anesthesia and to compare direct laryngoscopy and video laryngoscopy findings.
Adult patients with acromegaly and patients with nonfunctioning pituitary adenomas scheduled for surgery under general anesthesia will be prospectively enrolled between July 1, 2026, and August 31, 2026. Preoperative airway assessment parameters, hormonal data including growth hormone and insulin-like growth factor-1 levels, Mallampati score, modified Cormack-Lehane grade, intubation-related variables, and peri-intubation complications will be recorded.
Detailed description
This prospective observational study will be conducted at Basaksehir Cam and Sakura City Hospital between July 1, 2026, and August 31, 2026. The study population will include adult patients with acromegaly and adult patients with nonfunctioning pituitary adenomas who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
Eligible patients will undergo routine preoperative airway assessment. Recorded variables will include age, sex, height, body weight, body mass index, history of obstructive sleep apnea syndrome, comorbid diseases, previous operations, presence of hypopituitarism, preoperative growth hormone level, preoperative insulin-like growth factor-1 level, IGF-1 index, Mallampati score, and other airway-related clinical parameters.
During airway management, laryngoscopic findings obtained with direct laryngoscopy and video laryngoscopy will be recorded. The modified Cormack-Lehane classification will be used to assess glottic visualization. Intubation-related variables, including first-attempt success, time to successful intubation, number of intubation attempts, need for adjunct airway maneuvers or devices, oxygen desaturation, and airway trauma, will also be documented.
The primary objective of the study is to compare laryngoscopic findings and intubation characteristics in patients with acromegaly and to evaluate whether video laryngoscopy provides advantages over direct laryngoscopy in this patient group. The secondary objective is to identify clinical, hormonal, and airway-related predictors of difficult laryngoscopy or difficult intubation in patients with acromegaly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acromegaly Group | – | –Adult patients diagnosed with acromegaly who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation. |
| Nonfunctioning Pituitary Adenoma Group | – | –Adult patients diagnosed with nonfunctioning pituitary adenoma who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with acromegaly or nonfunctioning pituitary adenoma who are evaluated by the institutional pituitary diseases council and scheduled for elective surgery under general anesthesia requiring endotracheal intubation at Basaksehir Cam and Sakura City Hospital.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Diagnosis of acromegaly and scheduled for surgery after evaluation by the institutional pituitary diseases council
- Diagnosis of nonfunctioning pituitary adenoma and scheduled for surgery after evaluation by the institutional pituitary diseases council
- Requirement for general anesthesia with endotracheal intubation
- Ability and willingness to provide written informed consent
Key exclusion criteria (9 listed)
- Age younger than 18 years
- Refusal to participate in the study
- Presence of extrapituitary malignancy
- Emergency surgery
- Previous tracheostomy or major laryngeal/tracheal surgery
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
Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy
Time frame: During tracheal intubation procedure
The modified Cormack-Lehane grade obtained during direct laryngoscopy and video laryngoscopy will be recorded and compared to evaluate glottic visualization and the degree of laryngoscopic difficulty.
8 secondary outcomes
Mallampati Classification Score
Time frame: Preoperative airway assessment before induction of anesthesia
Time to Successful Intubation
Time frame: During tracheal intubation procedure
Number of Intubation Attempts
Time frame: During tracheal intubation procedure
Need for Adjunct Airway Maneuvers or Devices
Time frame: From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure
Peri-Intubation Oxygen Desaturation
Time frame: From anesthesia induction to 5 minutes after intubation
Airway Trauma
Time frame: Immediately after intubation
Association Between Growth Hormone Level and Difficult Laryngoscopy
Time frame: Baseline preoperative assessment and during the tracheal intubation procedure
Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy
Time frame: Preoperative baseline assessment and during the tracheal intubation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 24091425Friedel ME, Johnston DR, Singhal S, Al Khalili K, Farrell CJ, Evans JJ, Nyquist GG, Rosen MR. Airway management and perioperative concerns in acromegaly patients undergoing endoscopic transsphenoidal surgery for pituitary tumors. Otolaryngol Head Neck Surg. 2013 Dec;149(6):840-4. doi: 10.1177/0194599813507236. Epub 2013 Oct 3.
- Background: PubMed 19457671Ali Z, Bithal PK, Prabhakar H, Rath GP, Dash HH. An assessment of the predictors of difficult intubation in patients with acromegaly. J Clin Neurosci. 2009 Aug;16(8):1043-5. doi: 10.1016/j.jocn.2008.11.002. Epub 2009 May 19.
- Background: PubMed 28620866Zhang Y, Guo X, Pei L, Zhang Z, Tan G, Xing B. High levels of IGF-1 predict difficult intubation of patients with acromegaly. Endocrine. 2017 Aug;57(2):326-334. doi: 10.1007/s12020-017-1338-x. Epub 2017 Jun 15.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Only aggregated and anonymized study results may be presented in scientific meetings or published in peer-reviewed journals.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly and Nonfunctioning Pituitary Adenoma, run by Muzaffer GENCER.
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 5 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muzaffer Gencer, associate professor (+90 212 909 60 00, dr.m.gencer07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy (time frame: During tracheal intubation procedure). 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 NCT07659912, which also lists 3 linked publications.
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 22 Jun 2026.