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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yang Tao, Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01116999
First received: May 4, 2010
Last updated: September 25, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Tracheal Intubation Morbidity
Procedure: light guided tracheal intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Clinical Comparison of Direct Pharyngoscopic Tracheal Intubation Technique With Light-guided Tracheal Intubation

Further study details as provided by Second Military Medical University:

Primary Outcome Measures:
  • Ease to intubate (time and success rate required to perform intubation) [ Time Frame: Within 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tracheal intubation Procedure: light guided tracheal intubation
Tracheal intubation light guided technique.
Other Name: intubation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • neck and maxillofacial surgeries
  • temporomandibular joint (TMJ) disease
  • potential risks for regurgitation and pulmonary aspiration
  • in pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116999

Locations
China, Shanghai
Changhai Hospital Affiliated to Second Military Medical University
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Second Military Medical University
Investigators
Study Director: Tao Yang, MD Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Study Director: Jiong Hou, MD Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Study Director: Xiaoming Deng, Professor Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Principal Investigator: Xu Zhang, MD Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Principal Investigator: Wen Ni, MD Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
Principal Investigator: Xiaoyan Zhu, MD Second Military Medical University
Principal Investigator: Jinbao Li, MD Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital Affiliated to Second Military Medical University
  More Information

No publications provided

Responsible Party: Yang Tao, Department of Anesthesiology and Cirtical Care Medicine, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT01116999     History of Changes
Other Study ID Numbers: 19781007
Study First Received: May 4, 2010
Last Updated: September 25, 2011
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on November 24, 2014