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Nasotracheal Intubation Using Shikani Optical Stylet (SOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ru-Ping Dai, Central South University
ClinicalTrials.gov Identifier:
NCT00963677
First received: August 19, 2009
Last updated: May 1, 2012
Last verified: March 2012
History of Changes
  Purpose

Difficult airways is still a challenging issue for the anesthesiologists in spite of the development of various techniques.Shikani optical stylet(SOS), combining the features of fiberoptic bronchoscope and a lightwand, has been used for orotracheal intubation with difficult airways. As compared with fiberoptic bronchoscope, SOS is less expensive, easy to learn and more durable. However, it remains elusive whether SOS can be used in the nasotracheal intubation in the oral and maxillofacial surgery, which normally requires the nasotracheal intubation. The present study evaluates the safety and efficacy of SOS for nasotracheal intubation in the oral and maxillofacial surgery requiring nasotracheal intubation.


Condition Intervention
Intubation; Difficult
 Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation

Further study details as provided by Central South University:

Primary Outcome Measures:
  • Number of the Patients With Successful Nasotracheal Intubation [ Time Frame: 1 hour(peri-intubation time) ] [ Designated as safety issue: Yes ]
    After anesthesia induction, the patients were undergone nasotracheal intubation with SOS. Number for first time successful intubation was recorded. If the time for one attempt intubation exceeded more than 120 seconds, it would be regarded as failed intubation for this time intubation. If a patient could not be successfully intubated after three attempts, the patients would be viewed as a case failing nasotracheal intubation with SOS.


Secondary Outcome Measures:
  • Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet [ Time Frame: 1 hour (peri-intubation time) ] [ Designated as safety issue: Yes ]
    The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.


Enrollment: 55
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intubation without difficulty
The patients are not predicted for difficult intubation
 Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)
Nasotracheal intubation using seeing optical stylet in the patients with the anticipated difficult intubation. Arm 1:routine anesthesia induction,0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-0.15mg/kg vecuronium and 0.3mg/kg etomidate, Nasotracheal intubation with seeing optical shikani; Arms 2: Sevoflurane combined with oxyge, 0.3mg/kg Etomidate and 1-2mg/kg succinylcholine for intubation, nasotracheal intubation with seeing optical shikani
Other Name: fluoroscopy
Experimental: Difficult intubation
The patients will be anticipated for difficult intubation without difficult ventilation
 Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)
Nasotracheal intubation using seeing optical stylet in the patients with the anticipated difficult intubation. Arm 1:routine anesthesia induction,0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-0.15mg/kg vecuronium and 0.3mg/kg etomidate, Nasotracheal intubation with seeing optical shikani; Arms 2: Sevoflurane combined with oxyge, 0.3mg/kg Etomidate and 1-2mg/kg succinylcholine for intubation, nasotracheal intubation with seeing optical shikani
Other Name: fluoroscopy

Detailed Description:

The present study has been approved by the Research Ethics Committee of the Second Xiangya Hospital of Central South University . Informed and written consent will be obtained from patients who are undergoing oral and maxillofacial surgery requiring general anesthesia with nasotracheal intubation. Preoperative clinical assessment of the patients will include routine airway evaluation of dentition, mouth opening, tongue size, Mallampati score, and neck mobility.

For the patients without anticipated difficult intubations. Patients will be induced by the routine anesthesia fashion including 0.1mg/kg midazolam, 3-8mcg/kg fentanyl, 0.08-.015mg/kg vecuronium and 0.3mg/kg etomidate with standard preoxygen. The patients will be ventilated with 100% oxygen via bag and mask for 3 minutes.

For the patients with anticipated difficult airways. Patients will be inhaled with sevoflurane in 100% oxygen. Some protocols will be performed as the following: 1)If the patient can be ventilated with bag and mask after losing consciousness, 0.3mg/kg etomidate and 1-2mg/kg succinylcholine will be administered for muscle paralysis. If not, sevoflurane will be stopped and the patient will be awakened. Fiberoptic bronchoscope will be performed for the intubation; 2)If two attempts of intubation with SOS are failed, then the direct laryngoscope will be used for the intubation; If the intubation with direct laryngoscope is also failed, the patients will be awakened and intubated in the awake status.

After confirmation of the successful intubation, the routine anesthesia fashion will be followed and the surgery will be performed as the usual fashion.

Intubation time will be defined as the time from when Shikani stylet passes the nose of the patient until the time the endotracheal tube is positioned in the trachea. If the intubation sequence is longer than 120 seconds, it will be deemed a failure and recorded as such.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective non-cardiac surgery patients requiring intubation for the surgery. Age 18-70 ASA 1-3 Body Mass Index (BMI) < 40

Exclusion Criteria:

  • Patients confirmed with difficult ventilation;
  • Patients not suitable for nasal intubation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963677

Locations
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Sponsors and Collaborators
Central South University
Investigators
Principal Investigator: Ru-Ping Dai, MD, PhD Central South University
  More Information

No publications provided

Responsible Party: Ru-Ping Dai, Associate Professor, Central South University
ClinicalTrials.gov Identifier: NCT00963677     History of Changes
Other Study ID Numbers: NSFC-30700790, RDai-CSU
Study First Received: August 19, 2009
Results First Received: May 26, 2010
Last Updated: May 1, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Central South University:
Shikani optical stylet(SOS)
difficult airways
intubation

ClinicalTrials.gov processed this record on May 22, 2013