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Clinical Trials/NCT05317923
NCT05317923CompletedNot Applicable

Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial

Istanbul University1 site in 1 country24 target enrollmentStarted: March 14, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
PCO2

Study Overview

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.

Detailed Description

Tracheal stenosis is a serious complication following prolonged intubation. Two types of tracheal stenosis; Glottic and subglottic stenoses have common features in that they are challenging in terms of ventilation, oxygenation and intubation. However, there are important differences in the challenges of airway managementA thinner tube may be sufficient to overcome the airway difficulty in glottic stenoses. However, in subglottic tracheal stenosis, a thinner tube may not be conveyed to the distal of the stenosis. As a result, adequate ventilation and oxygenation may not be provided with an intubation tube placed proximal to the trachea. This study consists of our anesthesia management experience in patients with unusual placement of tracheal stenosis due to Covid-19 undergoing tracheal dilatation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

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

Intervention: Flow Controlled Ventilation (Other)

Outcomes

Primary Outcomes

PCO2

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

blood partial pressure of carbondioxide

PO2

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

blood partial pressure of oxygen

Secondary Outcomes

  • length of intubation due to Covid-19 Pnomonia(postoperative period (up to 1 year))
  • EtCO2(EtCO2 value at baseline just before entubation, 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)
  • sPO2(SPO2 value at baseline, peroperative 5, 15, 30, 45 minutes after induction, and before the extubation through surgery completion)
  • VAS (Visual Analogue Scale) score (between 0 to 10 points)(during surgery through surgery completion)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Demet Altun

Associate Professor

Istanbul University

Study Sites (1)

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