NCT06061380

Brief Summary

Management of a "difficult airway" remains one of the most relevant and challenging tasks for anesthesiologists and pulmonary physicians. Tracheal stenosis is not common but serious complication of prolonged intubation and tracheostomy patients. The incidence of stenosis is very low if intubation lasts less than a week and patients may be asymptomatic for a long time. On presentation, tracheal stenosis may be mistaken for asthma with dyspnea and stridor. The choice of treatment depends on the site, grade, and length of stenosis, as well as on patient comorbidities, history of previous interventions, and the expertise of the surgical team. In this case report the investigators wanted to present a case of a 25-year-old female with post-intubation tracheal stenosis who was intubated for the management of severe preeclampsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 23, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1 day

First QC Date

May 14, 2023

Last Update Submit

September 24, 2023

Conditions

Tracheal Stenosis

Outcome Measures

Primary Outcomes (1)

  • post-intubation tracheal stenosis

    The severity of tracheal stenosis was based on Cotton criteria confirmed by a Computerized tomography (CT) scan and the size of the tube that passed through it. If the Tracheal diameter is\> 8 mm but symptomatic mild, 5-8 mm moderate, and \<5 mm severe, and the effect of the severe tracheal stenosis was observed on anesthesia position, tracheal intubation technique, tube size that would challenge anesthesia management is reported

    the patient was follwed for 1 wk

Interventions

no intervation takenOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A mother developing post-intubation tracheal stenosis

You may qualify if:

  • Cases with tracheal stenosis caused by only prolonged intubation
  • Female

You may not qualify if:

  • Any tracheal stenosis caused by trauma, mass compression
  • Being male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dessie comprehensive specilized hospital

Dessie, Amhara, 801103, Ethiopia

Location

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract Diseases

Study Officials

  • Aynalem Bk Woldemichael, MSC

    Wollo Universty

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 14, 2023

First Posted

September 29, 2023

Study Start

January 23, 2021

Primary Completion

January 24, 2021

Study Completion

January 24, 2021

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)