search
Back to results

Predicting Post Extubation Stridor After Maxillomandibular Fixation (airway)

Primary Purpose

Stridor, Larynx Edema

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
budesonide
normal saline
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stridor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients (>18 years) American Society of Anesthesiologists status I and II undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation Exclusion Criteria: patients' refusal pregnant females patients with body mass index <18.5 or ≥ 35 kg/m2 risk of aspiration cardiorespiratory disorder neuromuscular disease uncontrolled diabetes mellitus gastrointestinal bleeding on chronic steroid therapy intubated patients or were intubated or had upper airway infection within 1 week prior to surgery history of any pathology, radiotherapy or surgery in the neck had difficult laryngeal US plane (as neck wound)

Sites / Locations

  • Maha Ahmed AboZeidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control (C) group

Budesonide (B) group

Arm Description

normal saline will be nebulized

budesonide will be nebulized

Outcomes

Primary Outcome Measures

Laryngeal air column width ratio

Secondary Outcome Measures

The duration of nasal endotracheal intubation
min
endotracheal tube insertion depth
cm
The incidence of epistasis occurrence during nasotracheal intubation
4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)
Expiratory tidal volume immediate after intubation with the cuff inflated
ml

Full Information

First Posted
April 21, 2023
Last Updated
May 3, 2023
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT05839756
Brief Title
Predicting Post Extubation Stridor After Maxillomandibular Fixation
Acronym
airway
Official Title
Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)
Detailed Description
Ultrasound (US) is a useful and non-invasive tool for the evaluation of vocal cords and laryngeal morphology in intubated patients. The laryngeal air-column width (LACW), Laryngeal air column width difference (LACWD), and laryngeal air-column width ratio (LACWR) measured by ultrasound can potentially identify patients at risk of post-extubation stridor, in whom caution should be taken after extubation. The cuff-leak test can predict successful extubation through using the difference between the expired tidal volume with the cuff inflated and with the cuff deflated; the higher the leak, the lower the likelihood that post-extubation stridor will occur.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stridor, Larynx Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated into two equal groups via opaque coded envelopes
Masking
ParticipantInvestigator
Masking Description
The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control (C) group
Arm Type
Placebo Comparator
Arm Description
normal saline will be nebulized
Arm Title
Budesonide (B) group
Arm Type
Active Comparator
Arm Description
budesonide will be nebulized
Intervention Type
Drug
Intervention Name(s)
budesonide
Intervention Description
2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
5 ml normal saline will be nebulized preoperatively
Primary Outcome Measure Information:
Title
Laryngeal air column width ratio
Time Frame
immediately before extubation
Secondary Outcome Measure Information:
Title
The duration of nasal endotracheal intubation
Description
min
Time Frame
Procedure (from nasal endotracheal intubation till extubation)
Title
endotracheal tube insertion depth
Description
cm
Time Frame
immediately after intubation
Title
The incidence of epistasis occurrence during nasotracheal intubation
Description
4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)
Time Frame
immediately after intubation
Title
Expiratory tidal volume immediate after intubation with the cuff inflated
Description
ml
Time Frame
immediately after intubation
Other Pre-specified Outcome Measures:
Title
Expiratory tidal volume immediate after intubation with the cuff deflated
Description
ml
Time Frame
immediately after intubation
Title
Expiratory tidal volume immediate before extubation with the cuff inflated
Description
ml
Time Frame
immediately before extubation
Title
Expiratory tidal volume immediate before extubation with the cuff deflated
Description
ml
Time Frame
immediately before extubation
Title
cuff leak volume
Description
ml
Time Frame
immediate after intubation and immediate before extubation
Title
Laryngeal air column width
Description
mm
Time Frame
before intubation
Title
Laryngeal air column width
Description
mm
Time Frame
immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation
Title
Laryngeal air column width
Description
mm
Time Frame
immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation
Title
Laryngeal air column width difference
Description
mm
Time Frame
immediate after intubation and immediate before extubation
Title
incidence of postoperative sore throat, dysphonia, swallowing disorders or PES.
Description
4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)
Time Frame
First postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (>18 years) American Society of Anesthesiologists status I and II undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation Exclusion Criteria: patients' refusal pregnant females patients with body mass index <18.5 or ≥ 35 kg/m2 risk of aspiration cardiorespiratory disorder neuromuscular disease uncontrolled diabetes mellitus gastrointestinal bleeding on chronic steroid therapy intubated patients or were intubated or had upper airway infection within 1 week prior to surgery history of any pathology, radiotherapy or surgery in the neck had difficult laryngeal US plane (as neck wound)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha A AboZeid, MD
Phone
02-01019216192
Email
mahazed@yahoo.com
Facility Information:
Facility Name
Maha Ahmed AboZeid
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha A AboZeid
Email
mahazed@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Predicting Post Extubation Stridor After Maxillomandibular Fixation

We'll reach out to this number within 24 hrs