Assessment of Airway in Patients With Acromegaly for Predicting Successful Tracheal Intubation

Brief Title

Assessment of Airway in Patients With Acromegaly for Predicting Successful Tracheal Intubation

Official Title

Assessment of Airway in Patients With Acromegaly Undergoing Surgery: Predicting Successful Tracheal Intubation

Brief Summary

      Acromegaly is associated with increased risk of difficult intubation and its management. The
      overall incidence of difficult intubation in patients suffering from acromegaly is four to
      five times more than those without acromegaly.The difficult intubation scenario in these
      patients can be managed by various methods ranging from awake fiberoptic intubation to
      tracheostomy. Difficult tracheal intubation accounts for 17% of respiratory-related injuries
      and results in significant morbidity and mortality in general population. In patients with
      acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related
      deaths. Therefore, the need and importance of airway assessment in patients with acromegaly
      cannot be overemphasized. Various tests of airway assessment have to be used to assess
      difficult airway and tracheal intubation in acromegalics.

      The investigators aim to assess the various tests of airway assessment affecting the outcome
      of patients with acromegaly undergoing pituitary surgery and identify which was best suited.

Detailed Description

All the patients of either gender, diagnosed as a case of acromegaly scheduled for pituitary
surgery will be enrolled. This observational study will be conducted over a period of 3
years. A written informed consent will be taken from all the patients. The clinical diagnosis
will be made on the basis of growth hormone (GH) levels and magnetic resonance imaging (MRI)
findings. All patients will be evaluated preoperatively, a day before surgery by an
independent observer. Airway assessment for difficult intubation will be performed using
Modified Mallampati classification in sitting and supine position followed by mouth opening,
upper lip bite test, measurement of thyromental, thyrohyoid, sternomental and hyomental
distance. Next the length of upper incisors, presence of receding mandible and neck movement
will be checked. An associated history of OSA will also be taken in to account for assessing
the difficult intubation followed by OSA grading in acromegalic patients posted for pituitary
surgery. In situation of difficult tracheal intubation the fiberoptic intubation would be the
preferred choice, which is a gold standard.

General anesthesia will be induced with fentanyl 2µg/kg, propofol 2 mg/kg and rocuronium
1mg/kg. After 90 seconds of mask ventilation, laryngoscopy will be performed with an
appropriate sized Macintosh laryngoscope and thereafter Cormac lehane grading will be noted.
External laryngeal manipulation (ELM) if carried out will be noted. A standard anesthesia
protocol will be followed. After completion of the surgery, neuromuscular blockade will be
reversed with neostigmine 0.05mg/kg and glycopyrrolate 0.01mg/kg intravenously. Once the
patient follows the verbal command and respiratory parameters are satisfactory, endotracheal
tube will be removed. All patients will be shifted to neurosurgical ICU for observation and
supportive management.

Study Type

Observational

Primary Outcome

Successful tracheal intubation

Secondary Outcome

 Rate of complications

Condition

Acromegaly

Intervention

Fiberoptic

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

March 2015

Completion Date

February 2018

Primary Completion Date

February 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Acromegalic patients undergoing surgery

        Exclusion Criteria:

          -  None

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Indu Kapoor, MD, 01126588500, [email protected]

Location Countries

India

Location Countries

India

Administrative Informations

NCT ID

NCT02403414

Organization ID

IEC/NP-397/14-11-2014

Responsible Party

Principal Investigator

Study Sponsor

All India Institute of Medical Sciences, New Delhi

Study Sponsor

Indu Kapoor, MD, Principal Investigator, All India Institute of Medical Sciences, New Delhi

Verification Date

January 2017