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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96103882
Enrollment
74
Registered
2007-09-28
Start date
2006-03-20
Completion date
Unknown
Last updated
2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery: Intubation Surgery Intubation

Interventions

Patients will be asked if they have any difficulty breathing through the nose. Only asymptomatic patients who report being able to breathe clearly through both nostrils will be invited to participate

Sponsors

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

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. Inclusion criteria: 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

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

Design outcomes

Secondary

MeasureTime frame
1. Resistance to the advancement of the tube through pathways 1 or 2. 2. Number of redirections of the tube needed before the tube advances through pathway 1 or 2 3. Incidence of nosebleed when the tube passes through pathway 1 or 2

Primary

MeasureTime frame
Proportion of Rae and Reinforced tubes advancing through the nose in pathway 1 and pathway

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026