Direct Versus Video Laryngoscopy in Patients With Acromegaly (ACRO-VL)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Muzaffer Gencer, associate professor
- Telefonnummer: +90 212 909 60 00
- E-mail: dr.m.gencer07@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Acromegaly Group
Adult patients diagnosed with acromegaly who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
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Nonfunctioning Pituitary Adenoma Group
Adult patients diagnosed with nonfunctioning pituitary adenoma who are scheduled for elective surgery under general anesthesia requiring endotracheal intubation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Modified Cormack-Lehane Grade With Direct and Video Laryngoscopy
Tidsramme: During tracheal intubation procedure
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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.
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During tracheal intubation procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Mallampati Classification Score
Tidsramme: Preoperative airway assessment before induction of anesthesia
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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.
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Preoperative airway assessment before induction of anesthesia
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Time to Successful Intubation
Tidsramme: During tracheal intubation procedure
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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.
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During tracheal intubation procedure
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Number of Intubation Attempts
Tidsramme: During tracheal intubation procedure
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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.
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During tracheal intubation procedure
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Need for Adjunct Airway Maneuvers or Devices
Tidsramme: From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure
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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.
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From induction of anesthesia until confirmation of successful endotracheal tube placement by capnography during the airway management procedure
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Peri-Intubation Oxygen Desaturation
Tidsramme: From anesthesia induction to 5 minutes after intubation
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Peri-intubation oxygen desaturation will be defined as a decrease in peripheral oxygen saturation below 90% during airway management.
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From anesthesia induction to 5 minutes after intubation
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Airway Trauma
Tidsramme: Immediately after intubation
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Airway trauma will be assessed by the presence of mucosal bleeding, dental trauma, lip injury, or other visible airway-related injury after intubation.
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Immediately after intubation
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Association Between Growth Hormone Level and Difficult Laryngoscopy
Tidsramme: Baseline preoperative assessment and during the tracheal intubation procedure
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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.
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Baseline preoperative assessment and during the tracheal intubation procedure
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Association Between Insulin-Like Growth Factor 1 Level and Difficult Laryngoscopy
Tidsramme: Preoperative baseline assessment and during the tracheal intubation procedure
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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.
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Preoperative baseline assessment and during the tracheal intubation procedure
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- 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.
- Ali 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.
- Zhang 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Knoglesygdomme
- Muskuloskeletale sygdomme
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer i endokrine kirtler
- Neoplasmer i nervesystemet
- Neoplasmer i centralnervesystemet
- Hypothalamus sygdomme
- Hypothalamiske neoplasmer
- Supratentoriale neoplasmer
- Neoplasmer i hjernen
- Hyperpituitarisme
- Hypofysesygdomme
- Knoglesygdomme, endokrine
- Hypofyse neoplasmer
- Akromegali
Andre undersøgelses-id-numre
- ACRO-VL-2026
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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