Nasotracheal Intubation Using Shikani Optical Stylet

NCT00963677 | Completed Results DMC

• 2 other identifiers: NSFC-30700790RDai-CSU
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Difficult

Keywords

Shikani optical stylet(SOS); difficult airways; intubation

Outcome Measures

Primary Outcomes (1)

• Number of the Patients With Successful Nasotracheal Intubation

  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.

  1 hour(peri-intubation time)

Secondary Outcomes (1)

• Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet

  1 hour (peri-intubation time)

Study Arms (2)

Intubation without difficulty

EXPERIMENTAL

The patients are not predicted for difficult intubation

Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)

Difficult intubation

EXPERIMENTAL

The patients will be anticipated for difficult intubation without difficult ventilation

Procedure: Nasotracheal Intubation through seeing optical stylet (SOS)

Interventions

Nasotracheal Intubation through seeing optical stylet (SOS) PROCEDURE

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

Also known as: fluoroscopy

Difficult intubation; Intubation without difficulty

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients confirmed with difficult ventilation;
• Patients not suitable for nasal intubation

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Results Point of Contact

• Title: Ru-Ping Dai, B.Sc(Med), PhD, Associate Professor
• Organization: The Second Xiangya Hospital of Central South University

Ruping_dai@yahoo.com.cn

86-731-85295970

Study Officials

• Ru-Ping Dai, MD, PhD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 21, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 3, 2012
• Results First Posted: May 3, 2012

Record last verified: 2012-03

Locations

CN (1)