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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

August 19, 2009
May 1, 2012
July 2009
November 2010   (final data collection date for primary outcome measure)
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.
Success rate of nasotracheal intubation [ Time Frame: 1 day (peri-intubation time) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00963677 on ClinicalTrials.gov Archive Site
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.
Time for nasotracheal intubation with the use of Shikani Optical Stylet [ Time Frame: 1 day (peri-intubation time) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Nasotracheal Intubation Using Shikani Optical Stylet
Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Intubation; Difficult
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: Intubation without difficulty
    The patients are not predicted for difficult intubation
    Intervention: Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)
  • Experimental: Difficult intubation
    The patients will be anticipated for difficult intubation without difficult ventilation
    Intervention: Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00963677
NSFC-30700790, RDai-CSU
Yes
Ru-Ping Dai, Central South University
Central South University
Not Provided
Principal Investigator: Ru-Ping Dai, MD, PhD Central South University
Central South University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP