Pathways through the nose in nasotracheal intubation: comparison of the Rae tube and the Reinforced tube

Not Applicable

Completed

• Conditions: Surgery; Intubation; Surgery: Intubation

• Registration Number: ISRCTN96103882
• Lead Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 74

Inclusion Criteria

The patients involved will be scheduled for elective surgery on maxillofacial operating lists. Patients admitted to the hospital on the day before surgery, or earlier, will be visited on their ward at least 24 hours before the planned surgery. It is not possible to adopt this approach in day-surgery patients (who are admitted on the day of surgery). It is important to ensure that these patients have sufficient time to consider whether they wish to be involved and also to give them an opportunity to discuss the research proposal with relatives or friends. The initial approach to these patients will therefore be by an invitation letter. This letter, accompanied by the Research Participant Information Sheet, will be sent to the patient with the admission documentation, approximately 2 to 3 weeks before admission. Patients will be recruited following clinical history taking and medical examination, Patients classified ASA 1 or 2, with no significant undercurrent illness, with inclusion criteria present and exclusion criteria absent, will be invited to consider participating in the trial. A full explanation will be given by the investigators and questions answered.

1. Patients in whom nasotracheal intubation is an essential part of their anaesthetic management. (It is not ethical to perform a potentially traumatic nasotracheal intubation unless it is required to facilitate the planned surgery).
2. ASA physical status 1 or 2 (Only patients who present no increased anaesthetic risks will be studied).
3. Aged 16 and over
4. Undergoing elective surgery (emergency surgery is associated with increased anaesthetic risks).
5. Asymptomatic patients who report being able to breathe clearly through the nose (if the patient has any significant nasal pathology e.g. nasal obstruction associated with septal deviation or sinusitis, then the pathway through the nose, taken by the tube, may be abnormal).
6. Able and willing to give informed written consent.

Exclusion Criteria

1. Morbid obesity
2. Oesophageal reflux
3. A history of nasal trauma or obstruction
4. Having a bleeding diathesis
5. Taking anticoagulant drugs
6. Patients expected to present difficult intubation will not be studied

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Rae and Reinforced tubes advancing through the nose in pathway 1 and pathway

Secondary Outcome Measures

Name	Time	Method
1. Resistance to the advancement of the tube through pathways 1 or 2.<br>2. Number of redirections of the tube needed before the tube advances through pathway 1 or 2<br>3. Incidence of nosebleed when the tube passes through pathway 1 or 2