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Completed

NCT Number: NCT02566135

I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie

Supraglottic Airway devices(SGAs) like I-Gel and C-LMA ( classic laryngeal mask airway ) have been used as a conduit for tracheal intubation using ventilating bougie. General Anaesthesia with tracheal intubation is one of the technique for giving anaesthesia. Tracheal intubation may become difficult sometimes and endangers patients life. Using SGAs as a conduit for tracheal intubation helps in securing airway. This will be further facilitated by using ventilating bougie, as it maintains oxygenation.

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Key information

Conditions

Intubation; Difficult

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

SGAs have been used as a conduit for tracheal intubation using ventilating bougie. Patients were anaesthetised with intravenous induction agent, non-depolarising muscle relaxant and then SGAs were inserted. Two groups were compared. In group I : I-gel was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then I-gel was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed. In group C : C-LMA was inserted, its position was confirmed and then ventilating bougie was inserted through it. It's position was confirmed, then C-LMA was removed , Endotracheal tube was railroaded over ventilating bougie and it's position was confirmed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 to 60 years
  • Gender : either sex
  • American society of Anaesthesiologist's Physical Status (ASAPS) I and II
  • Patients posted for surgery requiring general anaesthesia and endotracheal intubation.

Exclusion criteria

  • age <18 years and > 60 years
  • ASAPS III or IV
  • Obesity body mass index >25
  • Patients with mouth opening <2cms
  • Patients with Malampatti grade III and IV
  • Patients having history of gastro-esophageal reflux disease
  • Patients with history of inadequate fasting
  • Patients with known or anticipated difficult tracheal intubation or face-mask ventilation.

Treatment and study plan

Tracheal Intubation using I-gel and ventilating bougie

Device

Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.

Tracheal Intubation using C-LMA and ventilating bougie

Device

Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.

Primary outcomes

  1. Number of Attempts for I-gel or Classic-LMA Insertions

    Time frame: 60 seconds

  2. Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA

    Time frame: 45 seconds

  3. Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie

    Time frame: 30 seconds

  4. Time of Insertion

    Time frame: 5 minutes

  5. Total Intubation Time

    Time frame: 5 minutes

Secondary outcomes

  1. Heart Rate

    Time frame: 25 minutes

    Heart rate to observe at the following time intervals.

    • Base line
    • After induction
    • After dexmedetomidine injection
    • Supraglottic airway insertion
    • Ventilating bougie insertion
    • ETT insertion
    • 3minute after ETT insertion
    • 5 minute after ETT insertion
    • 7 minute after ETT insertion
    • 10 minute after ETT insertion
    • 15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here.

  2. Systolic Blood Pressure

    Time frame: 25 minutes

    Systolic blood pressure measured at following time intervals.

    • Base line
    • After Dexmedetomidine injection
    • After induction of anaesthesia
    • Supraglottic airway insertion
    • Ventilating bougie insertion
    • ETT insertion
    • 3 minute after ETT insertion
    • 5 minute after ETT insertion
    • 7 minute after ETT insertion
    • 10 minute after ETT insertion
    • 15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends.

  3. Diastolic Blood Pressure

    Time frame: 25 minutes

    Diastolic blood pressure measured at following time intervals.

    • Base line
    • After Dexmedetomidine injection
    • After Induction
    • Supraglottic airway insertion
    • Ventilating bougie insertion
    • ETT insertion
    • 3 minute after ETT insertion
    • 5 minute after ETT insertion
    • 7 minute after ETT insertion
    • 10 minutes after ETT insertion
    • 15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends.

Sponsors and collaborators

Lead sponsor

Medical College Baroda

Other

Registry information

Official study title

I-gel Versus C-LMA as a Conduit for Tracheal Intubation Using Ventilating Bougie

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2015
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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