Radiological Images for Nasotracheal Tube Size Estimation

Nasotracheal Tube Passage Through Nasal Cavity Clinical Trial

— RINSE  

Official title:

Nasal Cavity Evaluation by CT Scan/ Magnetic Resonance Imaging to Access the Size of Nasotracheal Tube for Nasal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675698
• Other study ID #: RES/SCM/30/2018/82
• Status: Completed
• Start date: October 25, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: June 2020
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This trial is planned to estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size .

Description:

The planned trial will estimate the size of nasotracheal tube (NTT) by calculating the diameter of both nasal cavity in radiological images of nose (CT scan/MRI) at the level below the inferior turbinate and floor of nose at different levels in coronal planes. Smallest diameter will be considered to calculate the outer diameter of NTT, hence the size. The side of nasotracheal intubation will be decided after view the radiological images and the estimated size of NTT will be used. Finally the ease of intubation and complications will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 10, 2020
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. patients requiring nasal intubation for oromaxillofacial surgeries

Exclusion Criteria:

• 1. Midface instability

2. Coagulopathy

3. Suspected basilar skull fractures

4. Large nasal polyps

5. Suspected nasal foreign bodies

6. Recent nasal surgery

7. History of frequent episodes of epistaxis

8. Prosthetic heart valves (increased risk of bacteremia during the insertion).

9. Patients with deranged liver and renal functions.

Related Conditions & MeSH terms

• Nasotracheal Tube Passage Through Nasal Cavity

Intervention

Other:
• Nasotracheal Intubation
side of nostril and size of endotracheal tube estimation for nasotracheal intubation will be done based on radiological imaging ( CT/MRI head)

Locations

Country	Name	City	State
India	Amit	Rohini	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

References & Publications (1)

Evans SW, McCahon RA. Management of the airway in maxillofacial surgery: part 2. Br J Oral Maxillofac Surg. 2018 Jul;56(6):469-474. doi: 10.1016/j.bjoms.2018.05.012. Epub 2018 Jun 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful nasal intubation by selecting the correct size of nasotracheal tube estimated by measuring the diameter of nasal cavity in coronal section just below the inferior turbinate in radiological images.	The diameter of both nasal cavities in coronal section of CT/MRI will be calculated at the level just below the inferior turbinate in anterior nasal cavity when inferior turbinates just appeared in the radiological image, than at level of maxillary sinus and just before cohanal opening in radiological images. Minimal diameter will be used to estimate the size of nasotracheal tube before intubation.The images will also be used to select the side of nasal intubation after ruling out any nasal pathology like DNS, Spurs and marked turbinate hypretrophy.	After enrolment of the patient and before intubation
Secondary	To find the complications associated with nasal intubations that were performed after assessing the radiological images.	The radiological images will be studied prior to intubation, the appropriate size of the nasotracheal tube will be selected and after ruling out any nasal pathology like DNS , spurs, concha bullosa side of nasal intubation will be decided.	At the time of intubation