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The Effect of Cold Vapor on Sore Throat and Dysphagia in the Early Postoperative Period After Suspension Laryngoscopy

Primary Purpose

Sore Throat, Dysphagia, Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold vapor
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat focused on measuring Sore throat, Dysphagia, Laryngoscopy, Nursing Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being 18 years or older
  • To undergo suspension laryngoscopy
  • Having an ASA score of 1-2 points
  • Not having any respiratory problems before the operation
  • Not having a neurological disease related to swallowing
  • Not having a sore throat due to cancer and chronic diseases
  • Having a Modified Mallampati score of 1-2 points
  • Getting 2 points from the Ramsay Sedation scale in the postoperative recovery room
  • Having a Modified Aldrete score of at least 9 points in the postoperative recovery room
  • The duration of the operation is at least 30 minutes
  • To be willing to participate in the study.

Exclusion Criteria:

  • To undergo emergency surgery
  • Being under the age of 18
  • Having an ASA score of 3 and above
  • Having any respiratory problems in the preoperative period
  • Having a neurological disease related to swallowing
  • Having a sore throat due to cancer and chronic diseases
  • Having a Modified Mallampati score of 3 or higher
  • The duration of the operation is less than 30 minutes
  • Not agreeing to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cold vapor group

    Control group

    Arm Description

    Cold vapor will be applied to the experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtime-un600a-ultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.

    Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of sore throat and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service.

    Outcomes

    Primary Outcome Measures

    Cold vapor
    The Visual Analogue Scale (VAS) of the patients for sore throat who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.
    Cold vapor
    The Numeric Rating Scale (RTS) of the patients for dysphagia who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the RTS. It is good that the score from the RTS has decreased.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2022
    Last Updated
    March 10, 2022
    Sponsor
    Istanbul Medeniyet University
    Collaborators
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05287698
    Brief Title
    The Effect of Cold Vapor on Sore Throat and Dysphagia in the Early Postoperative Period After Suspension Laryngoscopy
    Official Title
    The Effect of Cold Vapor on Sore Throat and Dysphagia in the Early Postoperative Period After Suspension Laryngoscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 21, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medeniyet University
    Collaborators
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Suspension laryngoscopy (SL) is a surgical procedure that is widely applied in the diagnosis and treatment of many benign or malignant diseases of the vocal cords and allows bimanual surgery of the endolarynx (Larner et al., 2019). In suspension laryngoscopy, a significant force is exerted on the tongue and neck tissues due to the abutment mechanism used to visualize the larynx and pharynx, which are located deeper than the oral cavity. This force causes symptoms such as sore throat, dysphagia, paresis, cough, taste disorder, oral injury, and hoarseness in the postoperative period (Larner et al., 2019; Tsang et al., 2020; Taliercio et al., 2017).In the literature, it has been reported that patients experience sore throat, cough, dysphagia, and hoarseness symptoms after suspension laryngoscopy (Larner et al., 2019; Taliercio et al., 2017; Okui et al., 2020). Pharmacological and non-pharmacological methods can be applied to prevent sore throat and dysphagia after suspension laryngoscopy. The interventions that start while the patient is still in the recovery room to prevent postoperative sore throat and swallowing difficulties are the responsibility of the recovery unit nurses. Being aware of the problems such as sore throat and swallowing difficulties experienced by patients after suspension laryngoscopy, effective nursing practices should be developed to prevent these problems and their possible consequences. Therefore, the aim of this study is to examine the effect of cold vapor on sore throat and dysphagia in the early postoperative period after suspension laryngoscopy.
    Detailed Description
    Suspension laryngoscopy (SL) is a surgical procedure that is widely applied in the diagnosis and treatment of many benign or malignant diseases of the vocal cords and allows bimanual surgery of the endolarynx (Larner et al., 2019).In order to prevent any pain and gag reflex, the patients are placed in the supine position, neck hyperextension and head supported position on the operating table for the intervention performed under general anesthesia. With this position, it is aimed to place the microlaryngoscope and to ensure the patient's throat opening (Tsang et al., 2020; Taliercio et al., 2017). In suspension laryngoscopy, a significant force is exerted on the tongue and neck tissues due to the abutment mechanism used to visualize the larynx and pharynx, which are located deeper than the oral cavity. This force causes symptoms such as sore throat, dysphagia, paresis, cough, taste disorder, oral injury, and hoarseness in the postoperative period (Larner et al., 2019; Tsang et al., 2020; Taliercio et al., 2017).In a study examining the complications experienced by patients after suspension laryngoscopy in the literature, Okui et al. reported that 66% of the patients experienced at least one complication, the most common complication was sore throat with 40%, and tongue numbness with 13.8%, cough with 13.4%, oral injuries with 11.5%, and taste disorders with 11.5% (Okui et al., 2020). In another study, it was reported that the most common postoperative complaints after suspension laryngoscopy were sore throat in 29% and hoarseness in 23% of the patients, while other less common symptoms were cough, frequent throat clearing, intermittent ear pain, and globus sensation (Larner et al., 2019). In another study, it was reported that 76% of the patients described a sore throat that continued for 3 days after the surgery, and that 36% of them continued after the 3rd day after the surgery (Taliercio et al., 2017). Pharmacological analgesic agents are frequently used to relieve symptoms of sore throat and dysphagia that occur in patients after suspension laryngoscopy (Jung and Kimm, 2013; Paltura et al., 2020). In the literature, there are many studies on the successful application of non-pharmacological agents in the treatment of pain (Bulut et al., 2016; Şahbaz and Khorshid, 2020; Zaman and Karahan, 2020; Guidelenes on the Management of Postoperative Pain, Management of Postoperative Pain, 2016). Patients with post-operative throat complaints are recommended practices that reduce complaints such as taking warm liquids, not taking solid food, sucking ice chips, using lozenges, and applying steam. The cold application creates vasoconstriction in the vessels in the area where it is applied, decreases the metabolic rate, and reduces edema. The cold application reduces muscle temperature by reducing the tension sensitivity of muscle spindles with the reflex effect of heat receptors or inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it decreases skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially useful in post-traumatic pain, swelling, and muscle spasm. Although it is seen that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat and dysphagia in the literature, no study has been found examining the effect of cold vapor on sore throat and dysphagia. Therefore, the aim of this study is to examine the effect of cold vapor on sore throat and dysphagia in the early postoperative period after suspension laryngoscopy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sore Throat, Dysphagia, Surgery
    Keywords
    Sore throat, Dysphagia, Laryngoscopy, Nursing Care

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients who were hospitalized for suspension laryngoscopy and met the sample selection criteria will be included in the experimental and control groups by block randomization method using the random numbers table on the computer.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cold vapor group
    Arm Type
    Experimental
    Arm Description
    Cold vapor will be applied to the experimental group patients for 15 minutes in the recovery room. For the study, Nebtime UN600A Ultrasonic Nebulizer Device will be used to apply cold steam to the patients which used in the hospital and calibrated (https://elmaslarmedikal.com.tr/urunler/nebtime-un600a-ultrasonik-nebulizator/). The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5 (1-10), air blowing intensity 5 (1-10), heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. Nursing care, which is routinely applied to patients in the postoperative period, both in the recovery room and in the service, will be continued within the standard care. The patients will be evaluated by the researchers in terms of sore throat and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service.
    Intervention Type
    Other
    Intervention Name(s)
    Cold vapor
    Intervention Description
    Before surgery, socio-demographic data of the patients, ASA and Mallampati scores, sore throat level, and dysphagia level will be recorded. After surgery, patients will be evaluated in the recovery room for their suitability to participate in the study with the Ramsay sedation scale and the Modified Aldrete Scale. Cold vapor will be applied to the patients for 15 minutes in the recovery room during the postoperative period. The parameters to be set on the device for the cold vapor to be applied to the patients in the early postoperative period will be vapor intensity level 5, air blowing intensity 5, heater intensity 1 (+10C), and timer 15 minutes. The patients will be evaluated by the researchers in terms of sore throat and dysphagia before and 15 minutes after the cold vapor application in the recovery room and at the 6th, 12th, and 24th hours after the cold vapor application in the postoperative service.
    Primary Outcome Measure Information:
    Title
    Cold vapor
    Description
    The Visual Analogue Scale (VAS) of the patients for sore throat who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the VAS. It is good that the score from the VAS has decreased.
    Time Frame
    First 24 hours after surgery
    Title
    Cold vapor
    Description
    The Numeric Rating Scale (RTS) of the patients for dysphagia who underwent cold vapor is decreased compared to those who do not. A score between 0 and 10 is taken from the RTS. It is good that the score from the RTS has decreased.
    Time Frame
    First 24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being 18 years or older To undergo suspension laryngoscopy Having an ASA score of 1-2 points Not having any respiratory problems before the operation Not having a neurological disease related to swallowing Not having a sore throat due to cancer and chronic diseases Having a Modified Mallampati score of 1-2 points Getting 2 points from the Ramsay Sedation scale in the postoperative recovery room Having a Modified Aldrete score of at least 9 points in the postoperative recovery room The duration of the operation is at least 30 minutes To be willing to participate in the study. Exclusion Criteria: To undergo emergency surgery Being under the age of 18 Having an ASA score of 3 and above Having any respiratory problems in the preoperative period Having a neurological disease related to swallowing Having a sore throat due to cancer and chronic diseases Having a Modified Mallampati score of 3 or higher The duration of the operation is less than 30 minutes Not agreeing to participate in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özlem İbrahimoğlu, PhD
    Phone
    +905436195971
    Email
    oogutlu@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bülent Evren Erkul, Professor
    Phone
    +905325993781
    Email
    evrenerkul@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    A decision will be made after consultation with other researchers.
    Citations:
    PubMed Identifier
    31360250
    Citation
    Larner SP, Fornelli RA, Griffith SD. Consistent Technique Limits Suspension Laryngoscopy Complications. Int Arch Otorhinolaryngol. 2019 Jul;23(3):e305-e310. doi: 10.1055/s-0039-1684036. Epub 2019 May 28.
    Results Reference
    background
    PubMed Identifier
    32151190
    Citation
    Tsang TM, Brett O, Hu A. Patient Perception and Duration of Pain after Microdirect Laryngoscopy. Otolaryngol Head Neck Surg. 2020 May;162(5):702-708. doi: 10.1177/0194599820907904. Epub 2020 Mar 10.
    Results Reference
    background
    PubMed Identifier
    28397564
    Citation
    Taliercio S, Sanders B, Achlatis S, Fang Y, Branski R, Amin M. Factors Associated With the Use of Postoperative Analgesics in Patients Undergoing Direct Microlaryngoscopy. Ann Otol Rhinol Laryngol. 2017 May;126(5):375-381. doi: 10.1177/0003489417693862. Epub 2017 Feb 1.
    Results Reference
    background
    PubMed Identifier
    31160183
    Citation
    Okui A, Konomi U, Watanabe Y. Complaints and Complications of Microlaryngoscopic Surgery. J Voice. 2020 Nov;34(6):949-955. doi: 10.1016/j.jvoice.2019.05.006. Epub 2019 May 31.
    Results Reference
    background
    PubMed Identifier
    24057101
    Citation
    Jung H, Kim HJ. Dexamethasone contributes to the patient management after ambulatory laryngeal microsurgery by reducing sore throat. Eur Arch Otorhinolaryngol. 2013 Nov;270(12):3115-9. doi: 10.1007/s00405-013-2708-5. Epub 2013 Sep 22.
    Results Reference
    background
    PubMed Identifier
    30227980
    Citation
    Paltura C, Guvenc A, Develioglu ON, Yelken K, Kulekci M. Original Research: Aerosolized Lidocaine: Effective for Safer Arousal After Suspension Laryngoscopy. J Voice. 2020 Jan;34(1):130-133. doi: 10.1016/j.jvoice.2018.08.012. Epub 2018 Sep 15.
    Results Reference
    background
    PubMed Identifier
    27444760
    Citation
    Bulut H, Erden S, Demir SG, Cakar B, Erdogan Z, Demir N, Ay A, Aydin E. The Effect of Cold Vapor Applied for Sore Throat in the Early Postoperative Period. J Perianesth Nurs. 2016 Aug;31(4):291-7. doi: 10.1016/j.jopan.2014.10.005. Epub 2016 Feb 24.
    Results Reference
    background
    PubMed Identifier
    32402773
    Citation
    Sahbaz M, Khorshid L. The Effect of Cold Vapor and Ice Cube Absorption in the Early Postoperative Period on Sore Throat and Hoarseness Induced by Intubation. J Perianesth Nurs. 2020 Oct;35(5):518-524. doi: 10.1016/j.jopan.2019.12.007. Epub 2020 May 10.
    Results Reference
    background
    PubMed Identifier
    26827847
    Citation
    Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
    Results Reference
    background
    Links:
    URL
    https://jag.journalagent.com/ejm/pdfs/EJM-18189-ORIGINAL_ARTICLE-KARAHAN.pdf
    Description
    Zaman, F. & Karahan, E. (2020). Effect of Cold Vapor Treated to Thyroidectomy Patients During Early Postoperative Period, East J Med 25(1): 118-125, DOI: 10.5505/ejm.2020.18189

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    The Effect of Cold Vapor on Sore Throat and Dysphagia in the Early Postoperative Period After Suspension Laryngoscopy

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