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NCT Number: NCT00963677

Nasotracheal Intubation Using Shikani Optical Stylet

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.

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Key information

Conditions

Intubation; Difficult

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: fluoroscopy

Primary outcomes

  1. Number of the Patients With Successful Nasotracheal Intubation

    Time frame: 1 hour(peri-intubation time)

    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 outcomes

  1. Time for Nasotracheal Intubation With the Use of Shikani Optical Stylet

    Time frame: 1 hour (peri-intubation time)

    The time of nasotracheal intubation was calculated from the SOS insertion to withdrawing the stylet from the endotracheal tube.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

Shikani Optical Stylet for Nasotracheal Intubation Undergoing Oral and Maxillofacial Surgery, a Prospective Evaluation

Acronym: SOS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 21, 2009
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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