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Not yet recruitingNCT07932509RCTUpdated Nov 12, 2026

Effect of Targeted Tracheal Kinesio Taping on Cough Efficacy and Decannulation Time in Burned Patients

An interventional study of Tracheal Kinesio Taping and Control in Burns, sponsored by MTI University. Not yet recruiting. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by MTI University · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

this study aims to evaluate the clinical efficacy of a novel, targeted tracheal Kinesio taping protocol as a complementary intervention to enhance airway clearance and expedite weaning milestones in severely burned patients. Specifically, we investigate the direct impact of this neurosensory and biomechanical airway modality on objective cough power-measured via Peak Cough Flow (PCF)-and its ultimate influence on total tracheostomy decannulation time. We hypothesize that the targeted application of tracheal Kinesio taping will safely stabilize airway structures, augment the explosive expiratory phase necessary for productive secretion clearance, and significantly shorten the temporal window required to achieve successful, complication-free decannulation in this vulnerable population.

Read the detailed description

The transition from a tracheostomy tube to independent, unassisted physiological respiration is a multifaceted clinical challenge that relies on several stringent criteria. Among these, a robust, forceful cough mechanism and the autonomous capability to manage abundant airway secretions stand out as the primary physiological predictors of decannulation readiness. In the burn population, this critical mechanism is heavily compromised. Inhalation injuries trigger an intense inflammatory cascade within the tracheobronchial tree, yielding thick mucus, cellular debris, and carbonaceous plugs. Concurrently, these patients suffer from profound respiratory muscle catabolism, vocal cord dysfunction, and severe pain-induced splinting originating from chest wall burns or fragile skin grafts. This systemic vulnerability drastically minimizes Peak Cough Flow (PCF), resulting in a high risk of mucus plugging, post-decannulation respiratory failure, and subsequent re-cannulation.

Conventional pulmonary rehabilitation strategies in the burn ICU primarily encompass early mobilization, targeted inspiratory and expiratory muscle training, manually assisted coughing, and aggressive mechanical suctioning. While these traditional methods are foundational, they often prove insufficient when restricted by severe patient exhaustion, dynamic skin contractures, or acute, pain-limited thoracic mobility. Furthermore, intensive suctioning can induce micro-trauma to the already inflamed, hyperemic airway mucosa. Given these limitations, there is a distinct clinical necessity for non-invasive, low-risk, and biologically supportive adjunct modalities that can optimize the biomechanical forces of expiration and airway clearance without compounding the patient's systemic pain burden or compromising fragile, healing dermal structures.

02

Conditions studied

  • Burns

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03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

MTI University is the lead sponsor of 62 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 65 years.
  • Admitted with severe burn injuries (total body surface area [TBSA] ≥ 20%) requiring a tracheostomy placed due to inhalation injury or prolonged mechanical ventilation.
  • Deemed hemodynamically stable and meeting standard institutional criteria for the initiation of weaning from mechanical ventilation (e.g., fractional inspired oxygen [\(FiO_{2}\)] ≤ 40%, positive end-expiratory pressure [PEEP] ≤ 5-8 \(cmH_{2}O\), and adequate spontaneous respiratory effort).

Exclusion criteria

Exclusion Criteria:

  • Full-thickness, unhealed burns, fresh skin grafts (\< 14 days post-operative), or active donor sites directly covering the anterior and lateral neck or upper chest taping zones.
  • Known or severe allergic dermal reactions to acrylic adhesives.
  • Pre-existing severe chronic neuromuscular disorders (e.g., Amyotrophic Lateral Sclerosis, Myasthenia Gravis) or structural upper airway abnormalities (e.g., high-grade tracheal stenosis, severe vocal cord paralysis) that independently impair cough capacity or contraindicate decannulation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Targeted Tracheal Kinesio Taping

    Participants randomized to the experimental group will receive targeted tracheal Kinesio taping as an adjunct to their daily pulmonary rehabilitation. A certified, KT-trained physical therapist will perform all applications using 5-cm wide, hypoallergenic, 100% cotton elastic tape (Kinesio® Tex Gold™). Before application, the skin surrounding the tracheostoma will be meticulously cleaned, degreased, and dried. Taping will be executed with the patient positioned in a comfortable, neutral cervical spine posture.

    Other: Tracheal Kinesio Taping

  • Active comparator
    Control

    standardized daily chest physiotherapy protocol tailored for burn critical care. This encompasses early progressive mobility and ambulation, targeted diaphragmatic breathing exercises, active-assisted or manually assisted coughing, oropharyngeal secretion suctioning, and mandatory compliance with the institution's progressive tracheostomy weaning pathway

    Other: Control

Interventions

  • OtherTracheal Kinesio Taping

    * Tracheal and Glottic Stabilization (Strip 1): An "I-strip" will be tailored to bridge horizontally across the anterior neck. The center of the tape will be applied directly superior to the tracheostoma flap (overlying the thyroid and cricoid cartilages) utilizing a facilitation tension of 25-35% stretch. This anchors structural airway positioning during explosive exhalation. The final 3 cm of each tail will be laid down laterally over the sternocleidomastoid muscles with 0% tension to act as neutral anchors. * Accessory Expiratory Muscle Assist (Strip 2): A "Y-strip" will be measured from the sternal notch to the clavicular heads. The base of the Y-strip will be anchored at the manubrium of the sternum with no tension. The two tails will then be directed superiorly and laterally along the trajectories of the infrahyoid and sternocleidomastoid muscles, applied with a light recoil tension of 15-20% stretch to biomechanically assist accessory expiratory acceleration during a cough.

  • OtherControl

    standardized daily chest physiotherapy protocol tailored for burn critical care. This encompasses early progressive mobility and ambulation, targeted diaphragmatic breathing exercises, active-assisted or manually assisted coughing, oropharyngeal secretion suctioning

06

What researchers measure

Primary outcomes

  1. Peak Cough Flow (PCF)expressed in Liters per minute, L/min

    Cough efficacy will be objectively measured using a calibrated, portable digital peak flow meter connected via an airtight respiratory adapter to the patient's fenestrated tracheostomy tube (with the cuff completely deflated and the proximal opening securely capped)

    Time frame: at base line and 2 weeks

Secondary outcomes

  1. Decannulation Time in days

    The temporal footprint of weaning will be recorded as the total number of days elapsed from the initiation of the weaning protocol (Day 0, defined as the first day of successful, stable mechanical ventilation independence) to the final, successful physical removal of the tracheostomy tube.

    Time frame: at base line and 2 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2026, 0 months later.

Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 0 months is below that.

Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 5, 2026
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07932509
Lead sponsor
MTI University
Responsible party
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d (ass.prof, MTI University) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 5, 2026 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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