NCT05317923

Brief Summary

Tracheal stenosis is a serious complication following prolonged intubation. There are important differences in the challenges of airway management. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

March 14, 2022

Last Update Submit

September 15, 2022

Conditions

Tracheal Stenosis

Keywords

prolonged intubation,tracheal stenosisCovid-19

Outcome Measures

Primary Outcomes (2)

  • PCO2

    blood partial pressure of carbondioxide

    PCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

  • PO2

    blood partial pressure of oxygen

    PO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

Secondary Outcomes (5)

  • EtCO2

    EtCO2 value at baseline just before entubation, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

  • length of intubation due to Covid-19 Pnomonia

    postoperative period (up to 1 year)

  • sPO2

    SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion

  • Myers-Cotton grading scale (1/2/3)

    before the surgery

  • VAS (Visual Analogue Scale) score (between 0 to 10 points)

    during surgery through surgery completion

Study Arms (1)

airway management and ventilation in patients with unusual placement of tracheal stenosis

EXPERIMENTAL

Flow-controlled ventilation (FCV) in patients with unusual placement of tracheal stenosis

Other: Flow Controlled Ventilation

Interventions

Flow Controlled VentilationOTHER

Anesthesia management in patients with subglottic tracheal stenosis with flow-controlled ventilation using an intubation tube with an inner diameter of less than 3 mm

airway management and ventilation in patients with unusual placement of tracheal stenosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2-3 patients over the age of 18 who are scheduled for an elective laryngeal procedure due to subglottic stenosis will be included in our study.

You may not qualify if:

  • Patients who did not agree to participate in the study.
  • Congestive heart failure (ejection fraction ≤ 35 %)
  • Emergency laryngeal procedures.
  • Patients under 18 years old.
  • Patients with ASA \> 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tracheal StenosisCOVID-19

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Officials

  • Istnabul University

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 8, 2022

Study Start

March 14, 2022

Primary Completion

June 30, 2022

Study Completion

September 1, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)