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Clinical Trials/CTRI/2025/08/092303
CTRI/2025/08/092303
Not yet recruiting
Not Applicable

Comparison of fiberoptic guided tracheal intubation through Blockbuster and Protector laryngeal mask airway

Government Medical College and Hospital, Chandigarh1 site in 1 country102 target enrollmentStarted: August 13, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Government Medical College and Hospital, Chandigarh
Enrollment
102
Locations
1
Primary Endpoint
To compare the time taken for fiberoptic-guided endotracheal intubation through the

Overview

Brief Summary

Supraglottic airway devices (SADs) are increasingly used in anaesthesia, critical care, and emergencies due to their ease of insertion and faster placement compared to endotracheal tubes (ETTs). They are also being used as conduits for ETT placement, offering benefits like reduced hemodynamic response and fewer complications. Among SADs, the LMA Blockbuster and LMA Protector are newer second-generation devices designed to aid intubation. The Blockbuster features a dual cuff and a preformed tube for better sealing and easier insertion, while the Protector has dual gastric drainage channels and a fixed curved shape. Although studies have compared these devices individually or with others, no direct comparison has been made between the Blockbuster and Protector for fiberoptic-guided intubation. This study hypothesizes that the Blockbuster may allow faster intubation due to its ergonomic design and dedicated ETT.

AIM

• Comparison of fiberoptic-guided tracheal intubation through Blockbuster and Protector

laryngeal mask airway.

PRIMARY OBJECTIVES

• To compare the time taken for fiberoptic-guided endotracheal intubation through the

Blockbuster and Protector laryngeal mask airway.

SECONDARY OBJECTIVES

• To compare the total time taken, the ease, number of attempts and any specific difficulties

observed during fiberoptic-guided endotracheal intubation through the two devices.

• To compare the fiberoptic assessment score of the glottic view, first attempt success rate of

ETI, oropharyngeal leak pressure (OLP).

• To compare the number of attempts required for insertion of the device, ease of insertion,

the insertion time and any postoperative adverse events with the two devices.

Methodology

Participants will be randomly assigned to either the Blockbuster group or the Protector

group.The study protocol outlines thorough pre anaesthesia workup including physical

examinations, various tests and assessment of difficult airway. Patients will be advised on fasting

and will be pre-medicated according to institutional guidelines. During anesthesia induction,

standard procedures will be followed, including pre-oxygenation, induction with propofol and

neuromuscular blockade. Airway management will vary based on group allocation, either with a

LMA Protector or LMA Blockbuster with specific

techniques outlined for each. Monitoring parameters, including hemodynamic parameters , will be closely observed at designated time points pre and

post-insertion of the airway devices. Analgesics and anti-emetics will be administered as necessary,

and reversal agents will be used post-surgery. The study will also evaluate the post-operative

complications like sore throat, dysphagia and dysphonia.

Outcomes

  1. Time taken for insertion of the endotracheal tube-

  2. Oropharyngeal leak pressure a) immediately ___________ b) 5 minutes after

insertion______________

  1. Ease of insertion [5-point Likert scale of difficulty (very difficult-1, difficult-2, neutral-3,

easy-4 and 5-very easy)]-

  1. Number of attempts at successful insertion–

  2. Time taken for insertion of SAD –

  3. Total time taken from insertion of SAD until endotracheal tube insertion-

  4. Fiberoptic grading of the laryngeal view through the study device –

  5. Intraoperative hemodynamic monitoring

9 Any intraoperative complication:

a) Device displacement

b) Soft tissue oedema

c) Dental trauma

10.Blood stain on study device immediately after removal-

  1. Post-operative observations: All patients will be evaluated in the post-anaesthesia care unit

for following:

a) Sore throat in post anaesthesia care unit (none, mild, moderate or severe)

b) Stridor or hoarseness

c) Any other relevant complication

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age between 18 to 60 years of either gender.
  • Patients with American Society of Anaesthesiologist (ASA) physical status class I and II.
  • 3.Patients undergoing elective surgery requiring controlled ventilation under general anaesthesia.

Exclusion Criteria

  • 1.Patient with anticipated difficult airway
  • Patient with BMI More than 35 kg per metre square
  • Pregnant women
  • Major maxillofacial trauma or c-spine injury
  • Severe Respiratory, cardiovascular, Renal, hepatic or masculoskeletal disease
  • Patient at increased risk of pulmonary aspiration such as GERD and peptic ulcer disease patients
  • Surgery in prone position.

Outcomes

Primary Outcomes

To compare the time taken for fiberoptic-guided endotracheal intubation through the

Time Frame: Time from | insertion of the fiberoptic bronchoscope into the respective SAD device until the first square | form capnography trace obtained on the monitor

Blockbuster and Protector laryngeal mask airway.

Time Frame: Time from | insertion of the fiberoptic bronchoscope into the respective SAD device until the first square | form capnography trace obtained on the monitor

Secondary Outcomes

  • Oropharyngeal leak pressure() immediately b) 5 minutes after)
  • Comparison of first attempt success rate,ease of insertion and number of attempts of Blockbuster and Protector laryngeal mask airway(After establishment of an effective airway)
  • To compare total time taken for fiberoptic-guided tracheal Intubation through Blockbuster and Protector laryngeal mask airway(After establishment of an effective airway)
  • To compare any specific difficulty observed during fiberoptic-guided tracheal Intubation through Blockbuster and Protector laryngeal mask airway
  • Fiberoptic grading of the laryngeal view through the study device
  • Intraoperative hemodynamic monitoring (NIBP,SPO2,HR,ETCO2)(Preop, Just before insertion, immediately after establishment of an effective airway, 5 minutes after establishment)

Investigators

Sponsor
Government Medical College and Hospital, Chandigarh
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

ABHISHEK

Government Medical College and Hospital, Chandigarh

Study Sites (1)

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