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Completed

NCT Number: NCT05317923

Airway Management During Unusual Tracheal Stenosis

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.

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Key information

Conditions

Tracheal Stenosis COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tracheal Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow Controlled Ventilation

Other

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

Primary outcomes

  1. 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

  2. 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

  1. EtCO2

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

    end-tidal carbondioxide measurement

  2. length of intubation due to Covid-19 Pnomonia

    Time frame: postoperative period (up to 1 year)

    time from intubation to extubation in ICU

  3. sPO2

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

    peripheral oxygen saturation

  4. Myers-Cotton grading scale (1/2/3)

    Time frame: before the surgery

    The grade of tracheal stenosis

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

    Time frame: during surgery through surgery completion

    surgeons' satisfaction(VAS 0=the worst view, 10= the best view)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Airway Management During Unusual Tracheal Stenosis: A Clinical Feasibility Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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