NCT04471467

Brief Summary

Nasotracheal intubation (NTI) is commonly used in operations of the mouth, pharynx, larynx and also the neck .Various complications can occur such as epistaxis, bacteremia,turbinectomy, retropharyngeal dissection, and nasal alar pressure sores or necrosis.In clinical practice, nasal pressure sores caused by NTI are not uncommon, but have failed to attract clinical attention.The investigators have observed that the surgeon fixed the nasal tracheal tube and threaded tube directly to the patient's head. The investigators suspect that this method can reduce the pressure between the nasal tube and the nose.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 12, 2020

Last Update Submit

July 18, 2020

Conditions

Keywords

nasotracheal intubationPressure Injury

Outcome Measures

Primary Outcomes (1)

  • pressure between the nasal tube and nose

    pressure between the nasal tube and nose under different conditions

    Immediately after procedure

Study Arms (2)

group F

Using tracheal tube fixation method (According to the needs of the surgery, the surgeon who did not participate in the trial)

Procedure: Fixed tracheal tube

group N

No tracheal tube fixation (According to the needs of the surgery, the surgeon who did not participate in the trial)

Interventions

Tracheal tube fixation is determined by the surgeon according to the needs of the operation and is an independent process. Our research simply installed a monitoring device between the tube and the nose. The tube fixation takes place whether the observation of pressures is agreed to or not, as per standard protocol.

group F

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who will be receiving general anesthesia with nasal intubation.

You may qualify if:

  • Age between 18-60 years old
  • ASA physical status I and II
  • Requiring general anesthesia with nasal intubation

You may not qualify if:

  • Previous history of pressure ulcers
  • Nasal trauma or defect
  • The need for emergency surgery
  • Contraindications to nasal intubation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 15, 2020

Study Start

July 20, 2020

Primary Completion

November 20, 2020

Study Completion

December 20, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07