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Completed

NCT Number: NCT01170455

Nasal Intubation Using the Blind Intubation Device

The purpose of this study is to determine whether nasal tracheal intubation using Blind Intubation Device is safe and effective in anesthetized patients with Mallampati class 3

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Shanghai 9th People's Hospital

Shanghai, Shanghai Municipality, 200011, China

About this study

The Blind Intubation Device (BID,Anhui Xiao Shan Hygienic Material Co.Ltd,Jixi County,China) is newly introduced for awake nasal intubation using a transillumination principle. For oral and maxillofacial surgery patients with anticipated difficult airways, the BID has a high rate of successful awake nasal intubation.Since the BID is more readily accessible,disposable and considerably less expensive,these advantages speak well for its use in China.However,to date,there is no study on its usage in anesthetized patients.The investigators hypothesized that a BID would be effective for nasal intubation in anesthetized patients with high Mallampati class and would result in fewer hemodynamic responses. To examine our hypothesis, the investigators would like to perform a prospective,randomized,controlled study to compare the effectiveness of the BID technique with a direct laryngoscope for nasal intubation in anesthetized patients with Mallampati class 3. The primary outcome measures are the hemodynamic changes during intubation. The investigators also would like to compare the intubation time required and associated airway complications in both groups as our second outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status 1-2
  • Scheduled for oral and maxillofacial surgery under general anesthesia with nasotracheal intubation
  • mallampati score 3

Exclusion criteria

  • ASA physical status 3-4
  • Patients with a history of intraoral,upper airway and neck surgeries
  • Patients with a history of chronic respiratory, cardiovascular or any other systemic diseases
  • morbid obesity
  • neck scars
  • mallampati score 4,inter-incisor distance<3cm, thyromental distance<6cm
  • unstable cervical spine
  • relevant drug allergy

Treatment and study plan

Macintosh laryngoscope

Device

nasal intubation with macintosh laryngoscope after general anesthesia induction

Blind Intubation Device

Device

nasal intubation using Blind Intubation Device after general anesthesia induction

Primary outcomes

  1. Hemodynamic changes

    Time frame: 1 min before general anesthesia induction

  2. Hemodynamic changes

    Time frame: 5 min after general anesthesia induction

  3. Hemodynamic changes

    Time frame: 30s from nasal intubation start

  4. Hemodynamic changes

    Time frame: 1 min after nasal intubation

  5. Hemodynamic changes

    Time frame: 2 min after nasal intubation

  6. Hemodynamic changes

    Time frame: 3 min after nasal intubation

  7. hemodynamic changes

    Time frame: 4 min from nasal intubation start

  8. hemodynamic changes

    Time frame: 5 min from nasal intubation start

Secondary outcomes

  1. intubation time required

    Time frame: 0 min after nasal intubation

    from taking of the intubation device to successful intubation

  2. immediate associated airway complications

    Time frame: 5 min after nasal intubation

    mucosal injury,dental injury,airway injury,bleeding, etc

  3. 24h associated airway complications

    Time frame: 24h after intubation

    sore throat, hoarseness, etc

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Registry information

Official study title

Nasal Intubation Using the Blind Intubation Device:a Prospective,Randomized,Controlled Comparison With the Direct Laryngoscope

Acronym: BID

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 27, 2010
Registry last updated
Oct 29, 2010

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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