Intubation ComplicationNCT05317156
The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period
A study testing Cold vapor in people with Intubation Complication and Cold, run by Istanbul Medeniyet University.
Trial summary
Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Complication, Cold, Sore Throat
- What is being tested?
- Cold vapor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Having an ASA score of 1-2
- 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
- Not having hoarseness before surgery
Show all 11Show fewer
- With endotracheal intubation, the duration of the operation is at least 60 minutes under general anesthesia.
- Having surgery in one of the prone and supine positions
- Getting 2 points from the Ramsay Sedation Scale in the postoperative recovery room.
- Having a Modified Aldrete score of at least 9 in the postoperative recovery room
- To be willing to participate in the study.
Who cannot join
- 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
Show all 10Show fewer
- Having throat surgery
- The duration of the operation is less than 60 minutes
- Having surgery in a position other than the prone and supine positions
- Not agreeing to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur.
Read the detailed description
Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. In addition, similar complaints may be encountered after extubation due to the displacement of the cuff of the EI and changes in the cuff pressure during the head and body positioning of the patient for surgical intervention after the EI. In the literature, studies examining the effect of intraoperative patient position on symptoms associated with postoperative intubation are limited. Baran Akkuş and Çaparlar (2020) evaluated the postoperative period of sore throat, hoarseness, dysphagia, and cough by controlling the cuff pressure in patients with hyperextension and supine position, and they did not find a significant difference between the groups. Although the severity of intubation-related complaints, which usually regress within 24 to 72 hours in the postoperative period, varies from patient to patient, it can affect the comfort of the patients in the early postoperative period.
In the literature, there are many studies conducted to relieve the symptoms of sore throat, cough, hoarseness, and dysphagia in patients after extubation. In these studies, pharmacological analgesic agents such as nonsteroidal anti-inflammatory drugs, steroids, opioids, local anesthetics; different anesthetic techniques, the use of different sized endotracheal tubes, intubation after complete muscle relaxation, minimizing cuff pressure, and lubricating gels such as local anesthetics or oral lozenges, sprays and mouthwash solutions are used around or inside the intubation tube cuff. There are many studies in the literature on the successful application of non-pharmacological agents in the treatment of pain. Patients with post-operative throat complaints are recommended to take warm liquids, avoid solid food, suck ice chips, use lozenges, and apply 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 by inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur. Although it is seen in the literature that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat, cough, hoarseness, and dysphagia, no study has been found examining the effect of the cold steam application on symptoms associated with IE.
- Conditions
- Intubation Complication, Cold, Sore Throat, Cough, Hoarseness, Dysphagia
- Being tested
- Cold vapor
- Keywords
- Intubation, Nursing care
- Medical subject headings
- Common Cold, Pharyngitis, Cough, Hoarseness, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold vaporOther
Before surgery, the socio-demographic data of the patients 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, cough, hoarseness, 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. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour.
| Study group | Role | What they receive |
|---|---|---|
| Prone position-Cold vapor group | Experimental | Cold vapor will be applied to the prone position 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/nebtimeun600aultrasonik-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, cough, hoarseness, 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. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. Receives: Other: Cold vapor |
| Supine position-Cold vapor group | Experimental | Cold vapor will be applied to the supine position 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/nebtimeun600aultrasonik-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, cough, hoarseness, 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. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. Receives: Other: Cold vapor |
| Prone position-Control group | No intervention | Patients in the prone position 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, cough, hoarseness, and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. |
| Supine position-Control Group | No intervention | Patients in the supine position 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, cough, hoarseness, and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold vapor
The sore throat, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 10 is taken from the Visual Analogue Scale (VAS). It is good that the score on the scales has decreased.
Measured: First 24 hours after surgery
Cold vapor
The cough, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 4 is taken from the Cough Severity Form (CSF). It is good that the score on the scales has decreased.
Measured: First 24 hours after surgery
Cold vapor
Swallowing, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 24 is taken from the Swallowing Impairment Score (SIS). It is good that the score on the scales has decreased.
Measured: First 24 hours after surgery
Cold vapor
The hoarseness, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 3 is taken from the Shout's Hoarseness Scale (SHS). It is good that the score on the scales has decreased.
Measured: First 24 hours after surgery
Cold vapor
The Perianesthesia Comfort Scale (PCS) of the patients for comfort who underwent cold vapor is decreased compared to those who do not. A score between 24 and 144 is taken from the PCS. It is good that the score from the PCS has increased.
Measured: 24th hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start18 Apr 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who were hospitalized for surgical intervention in the supine and prone position 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Maltepe University
- Responsible party
- Principal investigator, Dr. Özlem İbrahimoğlu, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317156
- Sponsor's protocol ID
- IstanbulMU13
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A decision will be made after consultation with other researchers.
Publications
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.
PubMed 27444760Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7.
PubMed 26149601Kim D, Jeon B, Son JS, Lee JR, Ko S, Lim H. The changes of endotracheal tube cuff pressure by the position changes from supine to prone and the flexion and extension of head. Korean J Anesthesiol. 2015 Feb;68(1):27-31. doi: 10.4097/kjae.2015.68.1.27. Epub 2015 Jan 28.
PubMed 25664152Jung TH, Rho JH, Hwang JH, Lee JH, Cha SC, Woo SC. The effect of the humidifier on sore throat and cough after thyroidectomy. Korean J Anesthesiol. 2011 Dec;61(6):470-4. doi: 10.4097/kjae.2011.61.6.470. Epub 2011 Dec 20.
PubMed 22220223Kim D, Jeong H, Kwon J, Kang S, Han B, Lee EK, Lee SM, Choi JW. The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial. Can J Anaesth. 2019 Aug;66(8):934-942. doi: 10.1007/s12630-019-01371-2. Epub 2019 Apr 16.
PubMed 30993537Komasawa N, Mihara R, Imagawa K, Hattori K, Minami T. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial. Biomed Res Int. 2015;2015:386080. doi: 10.1155/2015/386080. Epub 2015 Oct 5.
PubMed 26509152Paltura 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.
PubMed 30227980Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anesthesia. Anesthesiology. 1987 Sep;67(3):419-21. doi: 10.1097/00000542-198709000-00025. No abstract available.
PubMed 3307536Sahbaz 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.
PubMed 32402773
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Vapor on Intubation-Related Symptoms and Comfort in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT05317156
- Acronym / sponsor ID
- IstanbulMU13
- Conditions
- Intubation Complication, Cold, Sore Throat, Cough, Hoarseness, Dysphagia
- Keywords
- Intubation, Nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Maltepe University
- Study start
- 18 Apr 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur.
Detailed description
Endotracheal Intubation (EI) is performed in order to monitor the effectiveness of anesthesia and to control the patient's breathing during the surgery under general anesthesia. In EI, which is an invasive procedure, damage to the larynx and trachea may occur during the placement of the endotracheal tube or due to long-term use. Complications such as postintubation ulcer, laryngeal nerve paresis, arytenoid dislocation may develop in the early period due to EI, and patients may have complaints such as sore throat, swallowing problems, hoarseness, and cough in the postoperative period. In addition, similar complaints may be encountered after extubation due to the displacement of the cuff of the EI and changes in the cuff pressure during the head and body positioning of the patient for surgical intervention after the EI. In the literature, studies examining the effect of intraoperative patient position on symptoms associated with postoperative intubation are limited. Baran Akkuş and Çaparlar (2020) evaluated the postoperative period of sore throat, hoarseness, dysphagia, and cough by controlling the cuff pressure in patients with hyperextension and supine position, and they did not find a significant difference between the groups. Although the severity of intubation-related complaints, which usually regress within 24 to 72 hours in the postoperative period, varies from patient to patient, it can affect the comfort of the patients in the early postoperative period.
In the literature, there are many studies conducted to relieve the symptoms of sore throat, cough, hoarseness, and dysphagia in patients after extubation. In these studies, pharmacological analgesic agents such as nonsteroidal anti-inflammatory drugs, steroids, opioids, local anesthetics; different anesthetic techniques, the use of different sized endotracheal tubes, intubation after complete muscle relaxation, minimizing cuff pressure, and lubricating gels such as local anesthetics or oral lozenges, sprays and mouthwash solutions are used around or inside the intubation tube cuff. There are many studies in the literature on the successful application of non-pharmacological agents in the treatment of pain. Patients with post-operative throat complaints are recommended to take warm liquids, avoid solid food, suck ice chips, use lozenges, and apply 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 by inactivating trigger points in the muscles and helps to reduce muscle spasm. Thus, it reduces skin sensitivity by lowering the temperature of nerve fibers and receptors. Cold application is especially beneficial in post-traumatic pain, swelling, and muscle spasm. This affects the comfort of the patients in the postoperative period. For this reason, it is important to prevent intubation-related symptoms of patients who will undergo surgical intervention before they occur. Although it is seen in the literature that pharmacological, non-pharmacological, and herbal methods are applied to reduce postoperative sore throat, cough, hoarseness, and dysphagia, no study has been found examining the effect of the cold steam application on symptoms associated with IE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients who were hospitalized for surgical intervention in the supine and prone position 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.
| Arm | Type | Receives |
|---|---|---|
| Prone position-Cold vapor group | Experimental | Other: Cold vaporCold vapor will be applied to the prone position 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/nebtimeun600aultrasonik-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, cough, hoarseness, 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. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. |
| Supine position-Cold vapor group | Experimental | Other: Cold vaporCold vapor will be applied to the supine position 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/nebtimeun600aultrasonik-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, cough, hoarseness, 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. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. |
| Prone position-Control group | No intervention | –Patients in the prone position 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, cough, hoarseness, and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. |
| Supine position-Control Group | No intervention | –Patients in the supine position 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, cough, hoarseness, and dysphagia when they come to the recovery room and at the 6th,12th, and 24th hours after the surgery in the postoperative service. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being 18 years or older
- Having an ASA score of 1-2
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold vaporBefore surgery, the socio-demographic data of the patients 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, cough, hoarseness, 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. In addition, the comfort levels of the patients will be evaluated at the 24th postoperative hour. | Other | Prone position-Cold vapor group, Supine position-Cold vapor group |
Primary outcome
Cold vapor
Time frame: First 24 hours after surgery
The sore throat, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 10 is taken from the Visual Analogue Scale (VAS). It is good that the score on the scales has decreased.
Cold vapor
Time frame: First 24 hours after surgery
The cough, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 4 is taken from the Cough Severity Form (CSF). It is good that the score on the scales has decreased.
Cold vapor
Time frame: First 24 hours after surgery
Swallowing, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 24 is taken from the Swallowing Impairment Score (SIS). It is good that the score on the scales has decreased.
Cold vapor
Time frame: First 24 hours after surgery
The hoarseness, one of the intubation-related symptoms of the patients who underwent cold vapor, is decreased compared to those who do not. A score between 0 and 3 is taken from the Shout's Hoarseness Scale (SHS). It is good that the score on the scales has decreased.
Cold vapor
Time frame: 24th hour after surgery
The Perianesthesia Comfort Scale (PCS) of the patients for comfort who underwent cold vapor is decreased compared to those who do not. A score between 24 and 144 is taken from the PCS. It is good that the score from the PCS has increased.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 27444760Bulut 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.
- Background: PubMed 26149601Chang JE, Min SW, Kim CS, Han SH, Kwon YS, Hwang JY. Effect of prophylactic benzydamine hydrochloride on postoperative sore throat and hoarseness after tracheal intubation using a double-lumen endobronchial tube: a randomized controlled trial. Can J Anaesth. 2015 Oct;62(10):1097-103. doi: 10.1007/s12630-015-0432-x. Epub 2015 Jul 7.
- Background: PubMed 25664152Kim D, Jeon B, Son JS, Lee JR, Ko S, Lim H. The changes of endotracheal tube cuff pressure by the position changes from supine to prone and the flexion and extension of head. Korean J Anesthesiol. 2015 Feb;68(1):27-31. doi: 10.4097/kjae.2015.68.1.27. Epub 2015 Jan 28.
- Background: PubMed 22220223Jung TH, Rho JH, Hwang JH, Lee JH, Cha SC, Woo SC. The effect of the humidifier on sore throat and cough after thyroidectomy. Korean J Anesthesiol. 2011 Dec;61(6):470-4. doi: 10.4097/kjae.2011.61.6.470. Epub 2011 Dec 20.
- Background: PubMed 30993537Kim D, Jeong H, Kwon J, Kang S, Han B, Lee EK, Lee SM, Choi JW. The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial. Can J Anaesth. 2019 Aug;66(8):934-942. doi: 10.1007/s12630-019-01371-2. Epub 2019 Apr 16.
- Background: PubMed 26509152Komasawa N, Mihara R, Imagawa K, Hattori K, Minami T. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial. Biomed Res Int. 2015;2015:386080. doi: 10.1155/2015/386080. Epub 2015 Oct 5.
- Background: PubMed 30227980Paltura 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.
- Background: PubMed 3307536Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anesthesia. Anesthesiology. 1987 Sep;67(3):419-21. doi: 10.1097/00000542-198709000-00025. No abstract available.
- Background: PubMed 32402773Sahbaz 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.
- Paltura, C., \& Yüceant, G. A. (2018). Kısa süreli endotrakeal entübasyonun ses kalitesi ve aralığına etkisi. Çağdaş Tıp Dergisi, 8(1), 26-28.Link provided by the sponsor.
- Zaman, F., \& Karahan, E. (2020). The Effect of Cold Vapor Treated to Thyroidectomy Patients During Early Postoperative Period. Eastern Journal of Medicine, 25(1), 118-125.Link provided by the sponsor.
- Ghaleb, M. A., Falatah, S., \& Al-Amoudi, F. A. (2013). The efficacy of licorice gargle for attenuating postoperative sore throat. Am J Res Commun, 1(11), 379-94.Link provided by the sponsor.
- AKKUŞ, İ. B., \& ÇAPARLAR, C. Ö. (2020). Başın Hiperekstansiyonu Endotrakeal Kaf Basıncını Etkiler mi?. Turkiye Klinikleri J Anest Reanim, 18(1), 1-7.Link provided by the sponsor.
- Individual participant dataSharing planned: No. A decision will be made after consultation with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cold vapor in people with Intubation Complication and Cold, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem İbrahimoğlu, PhD (+905436195971, oogutlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cold vapor (time frame: First 24 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05317156, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.