Trial Outcomes & Findings for Assessment of a Novel Tracheostomy Tie (NCT NCT02820181)

NCT ID: NCT02820181

Last Updated: 2021-11-02

Results Overview

Nurses will be evaluated by Visual Analogue Scale/Score to measure the difficulty level of exchanging or cleaning the tracheostomy ties. Title: Visual Analogue Scale to measure the difficulty level of exchanging or cleaning the tracheostomy ties (0 to 10 ) Higher scores mean a worse outcome

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

14days

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Novel Tracheostomy Bi-ties those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.	Traditional Tracheostomy Tie those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of a Novel Tracheostomy Tie

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novel Tracheostomy Bi-ties n=30 Participants those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.	Traditional Tracheostomy Tie n=30 Participants those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.	Total n=60 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 2.9 • n=5 Participants	53.0 years STANDARD_DEVIATION 5.5 • n=7 Participants	53.7 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14days

Outcome measures

Outcome measures
Measure	Novel Tracheostomy Bi-ties n=30 Participants those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.	Traditional Tracheostomy Tie n=30 Participants those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome	1.2 score on a scale Standard Deviation 0.6	7.5 score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: 14days

Scale for breakdown of neck skin wound was rated as mild, moderate, or severe. "Mild" wounds included fragile skin that was erythematous or had a small amount of breakdown (\<1 cm in diameter). Wounds with evident skin erosion or breakdown associated with drainage and/or pain were classified as "moderate." "Severe" wounds were defined as a partial-thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed.

Outcome measures

Outcome measures
Measure	Novel Tracheostomy Bi-ties n=30 Participants those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.	Traditional Tracheostomy Tie n=30 Participants those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Number of Participants With Local Skin Breakdown None	30 Participants	27 Participants
Number of Participants With Local Skin Breakdown Mild	0 Participants	2 Participants
Number of Participants With Local Skin Breakdown Moderate	0 Participants	1 Participants
Number of Participants With Local Skin Breakdown Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 14days

Visual Analogue Scale/Score will be used to measure the degree of comfort of patients during wearing or exchanging tracheostomy ties Title: Visual Analogue Scale of comfort of patients during wearing or exchanging tracheostomy ties(0-10) Higher scores mean worse outcome.

Outcome measures

Outcome measures
Measure	Novel Tracheostomy Bi-ties n=30 Participants those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.	Traditional Tracheostomy Tie n=30 Participants those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome.	1.0 units on a scale Standard Deviation 0.7	8.9 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 14days

The record of the frequency of exchanging dressing under the tracheostomy ties in practice will be collected

Outcome measures

Outcome measures
Measure	Novel Tracheostomy Bi-ties n=30 Participants those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.	Traditional Tracheostomy Tie n=30 Participants those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Objective Index:the Actually Frequency of Exchanging Dressing	0 Times Standard Deviation 0	2 Times Standard Deviation 0.64

Adverse Events

Novel Tracheostomy Bi-ties

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional Tracheostomy Tie

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Jun Tian

The First Hospital of Shanxi Medical University

Phone: +8618612270351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place