CClinicalTrials.gg
CompletedNCT01116999Updated Sep 27, 2011

Retrograde Light Target Tracheal Intubation Technique:Clinical Comparison With Direct Pharyngoscopic Tracheal Intubation

An interventional study of light guided tracheal intubation in Tracheal Intubation Morbidity, sponsored by Second Military Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-09-27.

Sponsored by Second Military Medical University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The investigators hypothesise that, for novices, light guided tracheal intubation will improve the time and success rate of this clinical skill compared to standard direct tracheal intubation.

Read the detailed description

The experiment was conducted under the close supervision of the coaching anesthesiologists in several stages.

The training stage: First of all, the operators received training with respect to the theories and principles of airway management, including techniques of bag-mask ventilation, Direct laryngoscopy and tracheal intubation and light-guided and tracheal intubation until they had a good master about the theoretical background, technical risks and indications of the two techniques. Then, they had to receive manikin training of the two techniques on the Airway Management Trainer. Exposure of the glottis(EG)/tracheal intubation(TI) training would be continued before they were able to use both techniques to complete three consecutive cases of Exposure of the glottis/tracheal intubation operation successfully on the manikin trainer within 120 seconds (s) at a time.

20 medical workers were assigned to perform TI within 120s with either Direct laryngoscopy TI or light-guided TI technique, which was selected randomly and then converted to the alternative one until they complete 5 cases with each of the two techniques. The time of EG started from mouth opening of the patient to the exposure of the glottis. The time of TI also started from mouth opening of the patient to the completion of inserting the tracheal guide to the tracheal and sealing it with cuff inflation. The EG time, Cormack-Lehane (C\&L) grades, TI time, one-time success rate, and the overall success rate in using the two TI techniques were recorded.

The patient was laid in a supine position, with the head laid on a 7cm-high pillow for the sake of stability. The peripheral vein was accessed routinely and connected to a standard monitor for electrocardiography (ECG), SpO2 and noninvasive blood pressure (BP). Sufficient oxygen inhalation was initiated for > 3min before induction of general anesthesia with midazolam, propofol, fentanyl and rocuronium bromide. The anesthesiologist was not allowed to give any instruction and suggestion or assistance to the operator during the whole process. The coaching anesthesiologist supervised the whole TI process closely. Should any hidden risk occur or the TI exceed the required time of the experiment, the TI attempt of the operator would be terminated and replaced by the anesthesiologist in order to ensure patients' safety: TI exceeded 120s; Attempt of TI exceeded 2 times; SpO2 decreasing to below 95%; appearance of unstable hemodynamic situations (mean BP or HR fluctuating by more than 25% of the baseline value); or occurrence of airway injury as evidenced by stained blood on the Macintosh Blade. Any patient with C\&L grade III\~IV as discovered by the anesthesiologist during TI would be excluded from the present study and replaced by anther patient to re-start the experiment. A 7.0- or 7.5-mm-ID endotracheal tube was used as the guide according to the patient's condition.

02

Conditions studied

  • Tracheal Intubation Morbidity
03

In context

Lead sponsor

Second Military Medical University is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age range 18\~55 years
  • general anesthesia
  • ASA I\~II
  • Mallampati Score grade I\~II
  • thyromental distance ≥6cm
  • mouth-open ≥3cm
  • body mass index (BMI) ≤30kg/m2

Exclusion criteria

Exclusion Criteria:

  • neck and maxillofacial surgeries
  • temporomandibular joint (TMJ) disease
  • potential risks for regurgitation and pulmonary aspiration
  • in pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Tracheal intubation

    Procedure: light guided tracheal intubation

Interventions

  • Procedurelight guided tracheal intubation

    Tracheal intubation light guided technique.

    Also known as: intubation

06

What researchers measure

Primary outcomes

  1. Ease to intubate (time and success rate required to perform intubation)

    Time frame: Within 8 months

07

Study locations

1 site
  • Changhai Hospital Affiliated to Second Military Medical University
    Shanghai, Shanghai 200433, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01116999
Lead sponsor
Second Military Medical University
Responsible party
Yang Tao (Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital, Second Military Medical University) — Principal investigator
First posted
May 5, 2010
Start date
May 2010
Primary completion
Mar 2011
Completion
Apr 2011
Last update
Sep 27, 2011

Study contacts

Tao Yang, MD
study director · Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Jiong Hou, MD
study director · Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Xiaoming Deng, Professor
study director · Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Xu Zhang, MD
principal investigator · Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Wen Ni, MD
principal investigator · Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Xiaoyan Zhu, MD
principal investigator · Second Military Medical University
Jinbao Li, MD
principal investigator · Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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