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Radiological Images for Nasotracheal Tube Size Estimation (RINSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675698
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India

Brief 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 .

Condition or disease Intervention/treatment
Nasotracheal Tube Passage Through Nasal Cavity 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: Nasal Cavity Evaluation by CT Scan/ Magnetic Resonance Imaging to Access the Size of Nasotracheal Tube for Nasal Intubation
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : October 24, 2019
Actual Study Completion Date : March 10, 2020

Intervention Details:
  • 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)
    Other Name: Malinckrodt flexometallic tube


Primary Outcome Measures :
  1. 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. [ Time Frame: After enrolment of the patient and before intubation ]
    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.


Secondary Outcome Measures :
  1. To find the complications associated with nasal intubations that were performed after assessing the radiological images. [ Time Frame: At the time of intubation ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
oncosurgical patients with oral malignancies who required nasotracheal intubation for COMMANDO surgeries.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675698


Locations
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India
Amit
Rohini, Delhi, India, 110085
Sponsors and Collaborators
Rajiv Gandhi Cancer Institute & Research Center, India
Additional Information:

Publications:
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Responsible Party: Amit Kumar Mittal, Consultant in-charge, Rajiv Gandhi Cancer Institute & Research Center, India
ClinicalTrials.gov Identifier: NCT03675698    
Other Study ID Numbers: RES/SCM/30/2018/82
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India:
Nasotracheal tube size based on radiological images of nose.