None listed
Conditions
Brief summary
Patients in the intensive care unit (ICU) are known to be at higher risk of developing pressure injuries than other patient populations due to their illnesses and the types of therapies (medications, devices and technologies) used to treat their life-threatening event. More medical devices are used in critically ill patients because of the life-saving treatments needed and, thus, there are often high rates of medical device-related pressure injuries. Medical device-related pressure injuries are suspected when an injury has the same shape or outline as the device. Stomach tubes for feeding patients, and breathing tubes for mechanically assisted breathing, are the two most common devices used in ICUs. Together they cause the most medical device-related pressure injuries in the intensive care. Critically ill patients in the ICU with medical devices are nearly four times more likely to develop a pressure injury of any kind. There has been some research into ways to reduce medical device-related pressure injuries but none of these suggested methods have been tested in large patient groups. Hence, the aim of this project is to test the effectiveness of different ways of securing these devices, the use of a thin dressing under the device, regular assessment of your skin beneath the device, and regular repositioning of the device. The combination of these preventative methods in an intensive care environment has not been tested. This study will examine whether ICU patients with NGT or ETT who receive the intervention demonstrate less medical device related PI compared with patients who receive standard care practices.
Interventions
There are two arms of the study described below; Arm 1 - Nasogastric (NGT) securement devices with two interventions and a control; and Arm 2 - Endotracheal tube (ETT) securement devices with two interventions and a control.
ARM 1 (Wide bore NGT are left in situ for 3-5 days and then replaced with a fine bore NGT which can remain in situ indefinitely).
Subgroup 1A - NGT secured with tapes; Subgroup 1B NGT secured to ETT with TubeSAFE (Registered Trademark) clip.
Subgroup 1A participants’ NGT
There are two arms of the study described below; Arm 1 - Nasogastric (NGT) securement devices with two interventions and a control; and Arm 2 - Endotracheal tube (ETT) securement devices with two interventions and a control. ARM 1 (Wide bore NGT are left in situ for 3-5 days and then replaced with a fine bore NGT which can remain in situ indefinitely). Subgroup 1A - NGT secured with tapes; Subgroup 1B NGT secured to ETT with TubeSAFE (Registered Trademark) clip. Subgroup 1A participants’ NGT will be secured using self-adhesive tape (Hypafix [Registered Trademark], BSN Medical) attaching one end of the cotton tape to the nose over an anchoring dressing (DuoDERM [Registered Trademark] Extra Thin Dressing, ConvaTec), and attaching the other end to the nasogastric tube according to specific instructions. Subgroup 1B participants’ NGT will be secured using a TubeSAFE [Registered Trademark] clip which attaches the NGT to the ETT. All participants in subgroup 1A and 1B will receive the following intervention: 1) 12-hourly (i.e. each shift) application of 3M [Trademark] Cavilon No Sting Barrier film [Trademark] wipes, pre-packaged barrier wipes, on the nare surface around the device 2) Daily application of Mepilex [Registered Trademark] Lite (Molnlycke Health Care), a thin dressing, to pad the nare surface surrounding the device 3) Application of foam padding (3M), cut to wrap around the portion of the device in contact with the nare 4) 3-hourly assessment of the skin surrounding the device 5) 3-hourly repositioning of the device 6) Shift by shift documentation of all assessment, device positions, prevention strategies. ARM 2 (ETTs can remain in situ for 2-3 weeks depending on the patients projected clinical trajectory) Subgroup 2A - ETT secured with AnchorFast [Trademark] (Hollister [Registered Trademark] Inc.) ETT attachment device. All participants in this subgroup will receive the following intervention: 1) The participant’s cheek skin is clean, dry with no oily residue and no barrier wipe is applied 2) Tube attachment device applied and to remain in situ up to 5 days (as per manufacturer’s instructions) 3) Daily application of Mepilex [Registered Trademark] Lite (Molnlycke Health Care), a thin dressing, to pad the skin surface in the corners of the mouth 4) 3-hourly assessment of the skin surrounding the device 5) 3-hourly repositioning of ETT (right, centre or left) 6) Shift by shift documentation of all assessment, device position, prevention strategies. Subgroup 2B - ETT secured with tape and foam roll Subgroup 2B participants’ ETT will be secured using cotton tape secured around the ETT and tied around participants’ neck using foam to protect the skin at the nape of the neck and the cheeks. All participants in this subgroup will receive the following intervention: 1) 12-hourly application of a barrier wipe on the skin surface surrounding the device 2) 12-hourly repositioning of the device by resecuring the device (i.e. application of new tape and foam roll) 3) Daily application of Mepilex [Registered Trademark] Lite (Molnlycke Health Care), a thin padded dressing, on the skin/mucosal surface (corners of the mouth) surrounding the device 4) 3-hourly assessment of the skin underneath the device 5) Shift by shift documentation of all assessment, device position, prevention strategies. If the participant is eligible for both the NGT and ETT arms of the study they will be randomised to a subgroup in both arms. If a participant has both a NGT and ETT they will be first randomised to one of the three Arm 1 NGT subgroups (intervention [Subgroup 1A or Subgroup 1B] or the control group [Subgroup 1C]). Then the participant will be randomised to one of the three subgroups in Arm 2 ETT (intervention [Subgroup 2A or Subgroup 2B] or the control [Subgroup 2C]). The devices (NGTs and and ETTs) will be inserted respectively by appropriately trained nursing or medical personnel. Following intensive onsite training by the study investigators, bedside registered nurses in the intensive care units will administer the interventions. Adherence to the intervention delivery will be monitored by research nurses through completion of a checklist as part of the daily data collection. Feedback will be provided to the bedside registered nurses delivering the intervention.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All ICU patients = or >18 years who have a NGT and/or ETT in situ Patients who are expected to remain in ICU > 24 hours NGT or ETT inserted a maximum of 12 hours prior to ICU admission Patients readmitted to ICU with no oral or nasal skin injury present NGT arm only - must have wide bore NGT and an ETT in situ.
Exclusion criteria
Burn patients with an ETT wired in place (ETT arm only) Patients with NGT sutured in place or nasal bridle (NGT arm only) Patients with facial trauma Traumatic brain injured patients requiring intracranial pressure monitoring and/or ventricular drainage of cerebrospinal fluid Cervical spine injured patients who have a hard collar in situ Hirsute patients with beards where patient permission to shave is not possible Patients who are receiving non-invasive ventilation Patients with a device (NGT or ETT) predicted to be in situ < 48 hours. Patients with a community or hospital-acquired NGT or ETT PI diagnosed within 24 hours of admission to the ICU. Patients on whom treatment is withdrawn or who are being palliated. Patients currently enrolled on three studies in the ICU.
Outcome results
None listed