airway: Predicting Post Extubation Stridor After Maxillomandibular Fixation

• Sponsor: Mansoura University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05839756
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 7.8

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Stridor; Larynx Edema	Drug: budesonide; Drug: normal saline	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomly allocated into two equal groups via opaque coded envelopesPatients will be randomly allocated into two equal groups via opaque coded envelopes
• Masking: Double (Participant, Investigator)
• Masking Description: The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care
• Primary Purpose: Prevention
• Official Title: Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation
• Actual Study Start Date: May 3, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control (C) group normal saline will be nebulized	Drug: normal saline; 5 ml normal saline will be nebulized preoperatively
Active Comparator: Budesonide (B) group budesonide will be nebulized	Drug: budesonide; 2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively

Outcome Measures

Primary Outcome Measures

1. Laryngeal air column width ratio [immediately before extubation]

Secondary Outcome Measures

1. The duration of nasal endotracheal intubation [Procedure (from nasal endotracheal intubation till extubation)]

   min

2. endotracheal tube insertion depth [immediately after intubation]

   cm

3. The incidence of epistasis occurrence during nasotracheal intubation [immediately after intubation]

   4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)

4. Expiratory tidal volume immediate after intubation with the cuff inflated [immediately after intubation]

   ml

Other Outcome Measures

1. Expiratory tidal volume immediate after intubation with the cuff deflated [immediately after intubation]

   ml

2. Expiratory tidal volume immediate before extubation with the cuff inflated [immediately before extubation]

   ml

3. Expiratory tidal volume immediate before extubation with the cuff deflated [immediately before extubation]

   ml

4. cuff leak volume [immediate after intubation and immediate before extubation]

   ml

5. Laryngeal air column width [before intubation]

   mm

6. Laryngeal air column width [immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation]

   mm

7. Laryngeal air column width [immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation]

   mm

8. Laryngeal air column width difference [immediate after intubation and immediate before extubation]

   mm

9. incidence of postoperative sore throat, dysphonia, swallowing disorders or PES. [First postoperative day]

   4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maha Ahmed AboZeid	Mansoura		Egypt	35511

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: maha abou-zeid, Assistant Professor of Anesthesia and Surgical Intensive Care, Mansoura University
• ClinicalTrials.gov Identifier: NCT05839756
• Other Study ID Numbers: Post Extubation Stridor
• First Posted: May 3, 2023
• Last Update Posted: May 6, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Sounds; Budesonide

Study Results

No Results Posted as of May 6, 2023