Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475365
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-13
Brief Title:
Salt Water Gargling on Swallowing Following ACDF
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
The Effect of Salt Water Gargling on Swallowing Dysfunction Following Multi-Level Anterior Cervical Discectomy and Fusion ACDF A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride hereafter referred to as saltwater or saline in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion ACDF procedures The study population will consist of generally healthy adults ages 18 - 80 The main question it aims to answer is
If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water
Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery
Patients in the control arm will be asked to
- Complete three 3 questionnaires at specified intervals preoperative postoperative day POD 1 2 and 7 and at 1-month postoperatively
Patients in the experimentalinterventional arm will be asked to
Complete three 3 questionnaires at specified intervals preoperative postoperative day POD 1 2 and 7 and at 1-month postoperatively
Gargle with a warm saltwater solution once on POD 0 and thrice daily from POD 1 to POD 7
If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water
Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery
Patients in the control arm will be asked to
- Complete three 3 questionnaires at specified intervals preoperative postoperative day POD 1 2 and 7 and at 1-month postoperatively
Patients in the experimentalinterventional arm will be asked to
Complete three 3 questionnaires at specified intervals preoperative postoperative day POD 1 2 and 7 and at 1-month postoperatively
Gargle with a warm saltwater solution once on POD 0 and thrice daily from POD 1 to POD 7
Detailed Description:
Background Hypothesis
Dysphagia or difficulty swallowing often signifies structural or functional abnormalities in any of the three phases of swallowing and contributes to higher self-reported disability and lower physical health status Dysphagia is a common postoperative complication following anterior cervical discectomy and fusion ACDF procedures While most experience mild and transient symptoms some individuals endure severe dysphagia leading to significant postoperative morbidity
Several studies have demonstrated the efficacy of corticosteroids administered intraoperatively during ACDF procedures One prospective randomized double-blinded study showed favorable results with local corticosteroid administration resulting in a significant decrease in dysphagia during the immediate postoperative period to 1-month postoperatively Although other studies have also reported favorable outcomes with corticosteroid use they are still associated with considerable risks of adverse events Corticosteroids have been linked to a higher incidence of postoperative infection impairment of wound healing and a 2- to 5-fold increase in wound complications across a variety of surgical specialties
Salt water also known as saline is associated with anti-inflammatory anti-bacterial and wound healing properties Warm salt water rinses offer a more accessible cost-effective alternative to corticosteroids without their associated adverse effects The study aims to investigate the efficacy of gargling salt water in reducing the severity and symptoms of swallowing difficulties following multi-level ACDF procedures
This study is a single-center prospective randomized control trial Only patients 18 years of age who are undergoing a multi-level 2- 3- or 4-level ACDF and meet the general inclusion criterion will be invited to participate in the study
Methodology
1 Patients will be screened using the general inclusionexclusion parameters
2 Patients will be randomized into one of two groups control or experimental using a 11 ratio
3 Patients will complete three 3 questionnaires at selected time points throughout the study duration
4 Patients in the experimental arm will be asked to gargle with a saltwater solution one 1 time on POD 0 and three 3 times per day with approximately 15 milliliters mL per mouthful for seven 7 days POD 1 - POD 7 scheduled questionnaires
5 Patients in the control arm will only be asked to complete the scheduled questionnaires
Required questionnaires
1 Swallow Quality of Life Questionnaire SWAL-QOL
2 Visual Analogue Scale - Neck VAS Neck
3 Eating Assessment Tool EAT-10
General study execution
Patients in the interventional arm will be provided with a premade sodium chloride sterile saltwater solution 8-ounce-marked measuring cups and a detailed instruction sheet with the relevant contacts for the study
Dysphagia or difficulty swallowing often signifies structural or functional abnormalities in any of the three phases of swallowing and contributes to higher self-reported disability and lower physical health status Dysphagia is a common postoperative complication following anterior cervical discectomy and fusion ACDF procedures While most experience mild and transient symptoms some individuals endure severe dysphagia leading to significant postoperative morbidity
Several studies have demonstrated the efficacy of corticosteroids administered intraoperatively during ACDF procedures One prospective randomized double-blinded study showed favorable results with local corticosteroid administration resulting in a significant decrease in dysphagia during the immediate postoperative period to 1-month postoperatively Although other studies have also reported favorable outcomes with corticosteroid use they are still associated with considerable risks of adverse events Corticosteroids have been linked to a higher incidence of postoperative infection impairment of wound healing and a 2- to 5-fold increase in wound complications across a variety of surgical specialties
Salt water also known as saline is associated with anti-inflammatory anti-bacterial and wound healing properties Warm salt water rinses offer a more accessible cost-effective alternative to corticosteroids without their associated adverse effects The study aims to investigate the efficacy of gargling salt water in reducing the severity and symptoms of swallowing difficulties following multi-level ACDF procedures
This study is a single-center prospective randomized control trial Only patients 18 years of age who are undergoing a multi-level 2- 3- or 4-level ACDF and meet the general inclusion criterion will be invited to participate in the study
Methodology
1 Patients will be screened using the general inclusionexclusion parameters
2 Patients will be randomized into one of two groups control or experimental using a 11 ratio
3 Patients will complete three 3 questionnaires at selected time points throughout the study duration
4 Patients in the experimental arm will be asked to gargle with a saltwater solution one 1 time on POD 0 and three 3 times per day with approximately 15 milliliters mL per mouthful for seven 7 days POD 1 - POD 7 scheduled questionnaires
5 Patients in the control arm will only be asked to complete the scheduled questionnaires
Required questionnaires
1 Swallow Quality of Life Questionnaire SWAL-QOL
2 Visual Analogue Scale - Neck VAS Neck
3 Eating Assessment Tool EAT-10
General study execution
Patients in the interventional arm will be provided with a premade sodium chloride sterile saltwater solution 8-ounce-marked measuring cups and a detailed instruction sheet with the relevant contacts for the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None