Predicting Post Extubation Stridor After Maxillomandibular Fixation

NCT ID: NCT05839756

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Stridor Larynx Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly allocated into two equal groups via opaque coded envelopes
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care

Study Groups

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control (C) group

normal saline will be nebulized

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

5 ml normal saline will be nebulized preoperatively

Budesonide (B) group

budesonide will be nebulized

Group Type ACTIVE_COMPARATOR

budesonide

Intervention Type DRUG

2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively

Interventions

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budesonide

2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively

Intervention Type DRUG

normal saline

5 ml normal saline will be nebulized preoperatively

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maha Ahmed AboZeid

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Maha A AboZeid, MD

Role: CONTACT

02-01019216192

Facility Contacts

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Maha A AboZeid

Role: primary

Other Identifiers

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Post Extubation Stridor

Identifier Type: -

Identifier Source: org_study_id

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