Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal Intubation

Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal

In order to evaluate the safety and value of the improved ship-shaped fixing on tracheal intubation patients and provide theoretical basis for clinical therapy, we conducted this research to compare the fixed effectiveness, complications, nursing workload and medical expenses about application of ship-shaped adhesive tape fixation on patient undergoing tracheal intubation.

Study Overview

• Status: Completed
• Conditions: The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of Complications
• Intervention / Treatment: Behavioral: 3M tape ship-shaped combined with strap fixing method

Detailed Description

the fixed effectiveness：Incidence of catheter displacement，Incidence of unplanned extubation.

complications：Incidence f skin damage，Oral care effect，Incidence of ventilator-associated pneumonia.

nursing workload:Oral care is time-consuming medical expenses :Material economic cost

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with SICU intubation had been intubated for <8h at the time of entry (the interval of oral care was 8h);
• Patients with brain diseases or septic shock caused by abdominal infection;
• There was no pulmonary infection before endotracheal intubation.
• Facial skin integrity;
• Good oral cavity: no odor, no residue, no oral diseases, oral mucosa integrity;
• Informed consent is given by the family members and the informed consent is signed;
• No adhesive tape allergy.

Exclusion Criteria:

• Oral injury caused by suction;
• Endotracheal intubation time < 48 h;
• In the experiment is not willing to carry on the experiment, quit voluntarily.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M tape ship-shaped combined with strap fixing method; Cutting method of 3M adhesive tape of ship shape: cut a piece of 20cm×3cm elastic adhesive tape, fold it in half to form a rectangle of 10cm×3cm, cut 5cm straight line from the middle point of the crease, cut it at an Angle of 45°, fold and open the 3M elastic adhesive tape in half, which is the adhesive tape required for fixing. The final shape is similar to that of a ship, and it is named as 3M adhesive tape of ship shape.; Fixation method: The ship shape with 3M adhesive tape was pasted upward on the opposite cheek (near zygomatic), and the endotracheal intubation was wound around for two rounds and then glued to the near cheek (near zygomatic).Put the tooth pad next to the endotracheal intubation and wrap the tooth pad and catheter together for two turns with a short 3M adhesive tape of 12cm×1.5cm.Finally, fasten it with a lacing.	Behavioral: 3M tape ship-shaped combined with strap fixing method; During fixation, the endotracheal intubation and dental pad were located in the center of the mouth, and one end of one piece of medical cloth adhesive was pasted on the patient's cheek near the side. When it reached one side of the mouth, the endotracheal intubation and dental pad were wound around twice, and then the other side of the adhesive tape was pasted on the cheek opposite the side from the other side of the mouth,The other is fixed in reverse with the same sticking method, and the two pieces of adhesive tape are finally crossed and fixed at the corners of the mouth.Finally, fasten it with a lacing
No Intervention: traditional X-shaped tape and string fixing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the fixed effectiveness of endotracheal intubation	The tube displacement rate,	34 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications associated with endotracheal intubation fixation	Unplanned extubation,the occurrence of facial adhesive related skin injury,Effect of oral care	34 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic indicators	The cost of the tape required for the fixation	34 weeks
Nursing workload	Oral care takes a few minutes	34 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2018-144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No