Durapore vs. Hy-Tape to Secure The Endotracheal Tube

NCT ID: NCT03633877

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-10-11

Brief Summary

While adhesive tape is commonly used to secure endotracheal tubes (ETT) during general anesthesia, its use is also associated with facial skin injuries. Although a variety of adhesive tapes are used in clinical practice, few studies have investigated the likelihood of adhesives in producing injury. The purpose of this randomized, controlled, non-inferiority study was to compare the proportion of facial skin injury with Durapore™ vs. Hy-Tape®.

Detailed Description

Adhesive tapes are often used on the patient's face during general anesthesia. They are used to fix the tracheal tube, nasopharyngeal temperature probe, nasogastric tube, and nerve stimulator electrodes. An adhesive tape used in anesthesia needs to provide fast, secure adhesion to prevent dislodgement of critical devices. The tape should be secure over time, with changes over temperature, humidity, or exposure to fluids as occurring in the operating room. However, the tape should be gentle enough that removal should not cause skin trauma to the face. While the skin irritation is generally limited to mild erythema that resolves on its own within a day or two of receiving anesthesia, the irritation may affect patient satisfaction. Furthermore, serious injury, including full-thickness epidermal loss with purpura has occurred at Tufts Medical Center with the use of 3MTM Durapore tape, requiring several doctor visits in follow up.

Medical adhesive related skin injuries are estimated to impact at least 1.5 million patients annually in the US with significant costs per incident. (1) At Tufts Medical Center, a variety of adhesive tapes are used to secure the endotracheal tube during anesthesia, including 3MTM Durapore (acrylate- based tape) and the Hy-Tape® Pink tape (zink-based tape) with no preference for one or the other.

Hy-Tape's zinc oxide-based adhesive is claimed to be soothing to delicate skin, and removes with minimum trauma, thereby reducing the chance of skin tears and tape burns. It also has the unique quality of providing maximum adhesion when it reaches body temperature, without getting more aggressive or breaking down over time as acrylic-based adhesive tapes do. However, there is no scientific evidence to support this claim.

The purpose of this study is to compare the proportion of skin erythema after general anesthesia with the use of DuraporeTM vs. Hy-Tape®.

Conditions

Erythema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

DuraporeTM on R, Hy-Tape ® on L

DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia

Group Type: EXPERIMENTAL

DuraporeTM and Hy-Tape®

Intervention Type: DEVICE

Medical tapes

DuraporeTM on L, Hy-Tape ® on R

DuraporeTM and Hy-Tape® will be placed on patients' skin around the mouth during general anesthesia

Group Type: EXPERIMENTAL

DuraporeTM and Hy-Tape®

Intervention Type: DEVICE

Medical tapes

Interventions

DuraporeTM and Hy-Tape®

Medical tapes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18

2. Surgeries scheduled for anesthesia of duration more than 30 minutes after induction.

Exclusion Criteria

1. Any patient that does not consent

2. Patients < 18 years old

3. Surgery in the prone position

4. Surgery on the head, brain, neck, teeth, mouth, eyes, or face

Any patient who has:

5. Pre-existing skin erythema or other skin trauma

6. Lips piercings

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea L Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB#: 13029

Identifier Type: -

Identifier Source: org_study_id