Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575088
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Pneumatic Tourniquet Application in Upper Extremity Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Cuff Pressure Level and Protective Padding Material Selection on the Prevention of Skin Complications in Pneumatic Tourniquet Applications in Upper Extremity Surgery Clinical Research
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose This study investigated the effect of cuff pressure and the selection of protective padding materialPPM on the prevention of skin complications associated with pneumatic tourniquetPT application in upper extremity surgery
Methods This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX Standard tourniquet pressure STP or limb occlusion pressure LOP was applied as PT cuff pressure Cotton pads or elastic stockinette was used for PPM under the cuff Patients were categorized into four groups i STP with a cotton pad ii STP with an elastic stockinette iii LOP with a cotton pad and iv LOP with an elastic stockinette Total of 200 patients were included in the study with 50 patients in each group Skin complications were evaluated postoperatively at 0 30 and 180 min
Methods This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX Standard tourniquet pressure STP or limb occlusion pressure LOP was applied as PT cuff pressure Cotton pads or elastic stockinette was used for PPM under the cuff Patients were categorized into four groups i STP with a cotton pad ii STP with an elastic stockinette iii LOP with a cotton pad and iv LOP with an elastic stockinette Total of 200 patients were included in the study with 50 patients in each group Skin complications were evaluated postoperatively at 0 30 and 180 min
Detailed Description:
Pneumatic tourniquet PT is frequently used in extremity surgeries because of its advantages including better surgical field visibility and shorter operation duration Notwithstanding its advantages PT can cause a number complications in the postoperative period including pain edema skin complications muscle injuries thromboembolism and neurological damage Although the risks associated with the use of PT have decreased because of the introduction of adjustable pressure mechanisms and safety alarm systems complications can still occur Surgical team members should be knowledgeable about PT to ensure quality and safe patient care It is of great importance to evaluate the size and shape of the extremity and skin condition prior to PT application apply the appropriate size cuff and evaluate the skin under the cuff and peripheral pulses distal to the cuff upon application
There are different recommendations regarding safety practices for the application of PT in extremity surgeries Previous studies in the relevant literature reported controversial results regarding the appropriate tourniquet cuff pressure for extremity surgery and there are different applications for determining the cuff pressure Previous studies mostly used standard tourniquet pressure STP STP is defined as 250 mmHg pressure for the upper extremity and 300 mmHg pressure for the lower extremity Nevertheless minimum inflation pressures have been recommended instead of STP to prevent complications likely associated with high pressures Another method is the use of limb occlusion pressure LOP LOP is defined as the minimum pressure required to stop arterial blood flow into the extremity distal to the cuff LOP can be determined manually or automatically by slowly inflating the cuff and stopping the pulse using certain equipment including a Doppler flowmeter or pulse oximeter It was suggested that PT cuff pressure could be minimized by LOP application and that the risk of tourniquet-related complications could be reduced Most previous studies on PT have focused on the lower extremities Nevertheless tourniquet use also been the method of choice in upper extremity surgery to provide a surgical field without blood
In PT applications protective padding material PPM is placed between the skin and the cuff to prevent skin injuries The Association of Perioperative Registered Nurses recommends the application of soft low-lint padding materials including limb protection sleeves or two layers of stockinette plaster stocking The padding material should not compress the skin or cause wrinkles Fewer skin complications were observed in patients with cotton pads or elastic stockinette than in patients without PPM There is no material with proven superiority in the use of PPM
This study investigated the effects of cuff pressure level and the choice of PPM on the prevention of skin complications after PT in upper extremity surgery It was hypothesized that there was a relationship between the level of cuff pressure and the PPM during use and skin complications during PT applications in upper extremity surgery
There are different recommendations regarding safety practices for the application of PT in extremity surgeries Previous studies in the relevant literature reported controversial results regarding the appropriate tourniquet cuff pressure for extremity surgery and there are different applications for determining the cuff pressure Previous studies mostly used standard tourniquet pressure STP STP is defined as 250 mmHg pressure for the upper extremity and 300 mmHg pressure for the lower extremity Nevertheless minimum inflation pressures have been recommended instead of STP to prevent complications likely associated with high pressures Another method is the use of limb occlusion pressure LOP LOP is defined as the minimum pressure required to stop arterial blood flow into the extremity distal to the cuff LOP can be determined manually or automatically by slowly inflating the cuff and stopping the pulse using certain equipment including a Doppler flowmeter or pulse oximeter It was suggested that PT cuff pressure could be minimized by LOP application and that the risk of tourniquet-related complications could be reduced Most previous studies on PT have focused on the lower extremities Nevertheless tourniquet use also been the method of choice in upper extremity surgery to provide a surgical field without blood
In PT applications protective padding material PPM is placed between the skin and the cuff to prevent skin injuries The Association of Perioperative Registered Nurses recommends the application of soft low-lint padding materials including limb protection sleeves or two layers of stockinette plaster stocking The padding material should not compress the skin or cause wrinkles Fewer skin complications were observed in patients with cotton pads or elastic stockinette than in patients without PPM There is no material with proven superiority in the use of PPM
This study investigated the effects of cuff pressure level and the choice of PPM on the prevention of skin complications after PT in upper extremity surgery It was hypothesized that there was a relationship between the level of cuff pressure and the PPM during use and skin complications during PT applications in upper extremity surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None