Radiological Images for Nasotracheal Tube Size Estimation (RINSE)

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

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 .

Study Overview

• Status: Completed
• Conditions: Nasotracheal Tube Passage Through Nasal Cavity
• Intervention / Treatment: Other: Nasotracheal Intubation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• India
  • Delhi
    • Rohini, Delhi, India, 110085
      • Amit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

oncosurgical patients with oral malignancies who required nasotracheal intubation for COMMANDO surgeries.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): October 24, 2019
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: September 15, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Nasotracheal tube size based on radiological images of nose.
• Other Study ID Numbers: RES/SCM/30/2018/82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No