DysphagiaNCT02460055
Trial- Dysphagia From ETT or GI Endoscopy
A study testing endotracheal tube, propofol and Fentanyl in people with Dysphagia and Respiratory Complications, run by Baylor College of Medicine.
Trial summary
The purpose of this study is to conduct a randomized clinical trial to compare the incidence of dysphagia in patients receiving general anesthesia with and without an endotracheal tube for Upper gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Respiratory Complications
- What is being tested?
- endotracheal tube, propofol and Fentanyl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jun 2016
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients between the ages of 5-17 with normal cognitive function, without medical comorbidities who are scheduled to undergo esophagogastroduodenoscopy under general anesthesia will be recruited for the study
Who cannot join
- Patients under the age of five, or those between ages 5-17 years with cognitive delay or neurological disease scheduled to undergo Upper GI endoscopy will be excluded.
- Patients who currently have a sore throat or had a sore throat within the past one week will not be included in this study.
- Other patients with cardiopulmonary disease, coagulopathies, hepatorenal disease, endocrinological disease or airway abnormalities will also be excluded.
About this study
Official title: Randomized Controlled Trial Examining Effect Of Endotracheal Tube Intubation On Dysphagia In Children Presenting For Upper GI Endoscopy
The purpose of this study is to conduct a randomized clinical trial to compare the incidence of dysphagia in patients receiving general anesthesia with and without an endotracheal tube for Upper gastrointestinal endoscopy. If the incidence of dysphagia is found to be increased following endotracheal intubation for this procedure it could influence the investigators practice as anesthesiologists and may mandate the future routine use of laryngeal tracheal application of lidocaine at the time of intubation for example.
Read the detailed description
Patients between the ages of 5-17 with normal cognitive function presenting for Upper GI endoscopy will be considered for participation in this study. After consent is obtained from the parent/legal guardian, the patient will undergo a general anesthetic to facilitate the procedure. All patients in this study will receive a general anesthetic. Following routine inhalation induction with 8% sevoflurane in oxygen and nitrous oxide, 100% oxygen will be administered and intravenous access will be secured. Intravenous administration of Propofol 3mg/kg and Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation with an age appropriate endotracheal tube for children randomized to receive endotracheal intubation. Following endotracheal intubation, the oropharynx will be auscultated for the presence of an audible air leak around the endotracheal tube. If an audible leak is appreciated below 20cm of H2O pressure, the cuff of the endotracheal tube will be gradually inflated with air until the audible leak is no longer appreciated. This is routine practice following endotracheal intubation. The endotracheal tube will not be lubricated prior to intubation. Those not receiving endotracheal intubation will undergo an inhalation induction, have intravenous access secured and intravenous propofol 3mg/kg with Fentanyl 1mcg/kg will be administered prior to placement of the nasal trumpet and connection to the anesthesia circuit. Both arms of patients will receive a general anesthetic consisting of sevoflurane in oxygen and air at routine concentrations for maintenance of anesthesia either via the endotracheal tube or via nasal trumpet for the Upper GI endoscopy procedure. Other medications that will be administered during the procedure to both arms of patients include Dexamethasone which will be administered at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg for post operative nausea and vomiting prophylaxis. Additional maneuvers which may aggravate post operative dysphagia such as the use of a Yankauer suction catheters, placement of nasopharyngeal temperature probes and coughing during emergence prior to extubation of the patient will be avoided. Utilization of soft tip suction catheters and skin or axilla temperature probes will be employed and the trachea will be extubated under deep anesthesia. Data that will be collected will include: Pre-operative data: the recent need of breathing treatments, allergy history and smokers at home. Intraoperative data: the presence of bucking/coughing during intubation, experience level of the intubating practitioner, laryngoscopic view, endotracheal tube size, number of intubation attempts, experience of the endoscopist, size of the endoscope used and duration of the procedure. With both techniques (intubation and nasal trumpet use), the data that will be collected will include: Coughing or bucking prior to extubation or during emergence and removal of nasal trumpet, occurence of laryngospasm, bronchospasm or desaturation less than 95% requiring treatment , breath-holding and methods for resolution. PACU data: Incidence of laryngospasm, breath-holding, or apnea, presence or absence of nausea/vomiting and if treatment was required, requirement of additional pain medication, documentation of dysphagia prior to the first oral intake and grading of the sore throat as previously documented. Postoperatively, the presence of dysphagia will be sought at two different time points: Via face to face interview in the post operative anesthesia care unit (PACU) prior to the first per oral intake and 24 hours later at which point presence/absence of dysphagia will be ascertained via phone. Complaints will be graded according to a scoring system (Capon LM et al. Anesthesiology 1983) : Presence of sore throat (ST): Yes/No If No, ST will be graded as 0= no sore throat If Yes, ST will be graded 1-3 as follows: 1=mild sore throat (pain with swallowing) 2=moderate sore throat (pain present constantly and worsens with swallowing) 3=severe sore throat (pain interferes with eating and requires analgesic medication for relief). Pain will also be assessed with a VAS score immediately postoperatively and at 24 hours
- Conditions
- Dysphagia, Respiratory Complications
- Being tested
- endotracheal tube, propofol, Fentanyl, Dexamethasone, Ondansetron
- Keywords
- EGD Dysphagia, ETT Intubation dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endotracheal tubeDevice
This study will determine if the placement of an ETT will lead to dysphagia.
propofolDrug
propofol 3mg/kg will be administered to facilitate endotracheal intubation
FentanylDrug
Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation
DexamethasoneDrug
Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis
OndansetronDrug
Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis
sevoflurane, nitrous oxide and oxygenDrug
Inhalational agents will be used to induce general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal tube | Active comparator | Following routine inhalation induction with 8% sevoflurane in oxygen and nitrous oxide, 100% oxygen will be administered and intravenous access will be secured. Intravenous administration of Propofol 3mg/kg and Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation with an age appropriate endotracheal tube. Presence of an audible air leak around the endotracheal tube will be addressed by inflating the cuff with air until the audible leak is no longer appreciated. The endotracheal tube will not be lubricated prior to intubation. Other medications that will be administered during the procedure include Dexamethasone at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg. Receives: Device: endotracheal tube; Drug: propofol; Drug: Fentanyl; Drug: Dexamethasone; Drug: Ondansetron; Drug: sevoflurane, nitrous oxide and oxygen |
| No Endotracheal tube | Active comparator | Those not receiving endotracheal intubation will undergo an inhalation induction, have intravenous access secured and intravenous propofol 3mg/kg with Fentanyl 1mcg/kg will be administered prior to placement of the nasal trumpet and connection to the anesthesia circuit.patients will receive a general anesthetic consisting of sevoflurane in oxygen and air at routine concentrations for maintenance of anesthesiaOther medications that will be administered during the procedure to both arms of patients include Dexamethasone which will be administered at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg for post operative nausea and vomiting prophylaxis. Receives: Drug: propofol; Drug: Fentanyl; Drug: Dexamethasone; Drug: Ondansetron; Drug: sevoflurane, nitrous oxide and oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dysphagia
Dysphagia will be determined by a scale ( 0=no sore throat, 1=mild sore throat, 2=moderate sore throat, 3=severe sore throat) and Visual analog scale .
Measured: up to 24 hours
Secondary outcomes (1)
Patient Satisfaction
Patient satisfaction will be measured by a patient satisfaction survey prior to discharge from PACU
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2016
Why it stopped: no subject met enrollment criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imelda Michelle Tjia, Baylor College of Medicine
- Investigators
- Imelda M Tjia, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460055
- Sponsor's protocol ID
- H-32691
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2015
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Examining Effect Of Endotracheal Tube Intubation On Dysphagia In Children Presenting For Upper GI Endoscopy
- ClinicalTrials.gov ID
- NCT02460055
- Acronym / sponsor ID
- H-32691
- Conditions
- Dysphagia, Respiratory Complications
- Keywords
- EGD Dysphagia, ETT Intubation dysphagia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subject met enrollment criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
The purpose of this study is to conduct a randomized clinical trial to compare the incidence of dysphagia in patients receiving general anesthesia with and without an endotracheal tube for Upper gastrointestinal endoscopy. If the incidence of dysphagia is found to be increased following endotracheal intubation for this procedure it could influence the investigators practice as anesthesiologists and may mandate the future routine use of laryngeal tracheal application of lidocaine at the time of intubation for example.
Detailed description
Patients between the ages of 5-17 with normal cognitive function presenting for Upper GI endoscopy will be considered for participation in this study. After consent is obtained from the parent/legal guardian, the patient will undergo a general anesthetic to facilitate the procedure. All patients in this study will receive a general anesthetic. Following routine inhalation induction with 8% sevoflurane in oxygen and nitrous oxide, 100% oxygen will be administered and intravenous access will be secured. Intravenous administration of Propofol 3mg/kg and Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation with an age appropriate endotracheal tube for children randomized to receive endotracheal intubation. Following endotracheal intubation, the oropharynx will be auscultated for the presence of an audible air leak around the endotracheal tube. If an audible leak is appreciated below 20cm of H2O pressure, the cuff of the endotracheal tube will be gradually inflated with air until the audible leak is no longer appreciated. This is routine practice following endotracheal intubation. The endotracheal tube will not be lubricated prior to intubation. Those not receiving endotracheal intubation will undergo an inhalation induction, have intravenous access secured and intravenous propofol 3mg/kg with Fentanyl 1mcg/kg will be administered prior to placement of the nasal trumpet and connection to the anesthesia circuit. Both arms of patients will receive a general anesthetic consisting of sevoflurane in oxygen and air at routine concentrations for maintenance of anesthesia either via the endotracheal tube or via nasal trumpet for the Upper GI endoscopy procedure. Other medications that will be administered during the procedure to both arms of patients include Dexamethasone which will be administered at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg for post operative nausea and vomiting prophylaxis. Additional maneuvers which may aggravate post operative dysphagia such as the use of a Yankauer suction catheters, placement of nasopharyngeal temperature probes and coughing during emergence prior to extubation of the patient will be avoided. Utilization of soft tip suction catheters and skin or axilla temperature probes will be employed and the trachea will be extubated under deep anesthesia. Data that will be collected will include: Pre-operative data: the recent need of breathing treatments, allergy history and smokers at home. Intraoperative data: the presence of bucking/coughing during intubation, experience level of the intubating practitioner, laryngoscopic view, endotracheal tube size, number of intubation attempts, experience of the endoscopist, size of the endoscope used and duration of the procedure. With both techniques (intubation and nasal trumpet use), the data that will be collected will include: Coughing or bucking prior to extubation or during emergence and removal of nasal trumpet, occurence of laryngospasm, bronchospasm or desaturation less than 95% requiring treatment , breath-holding and methods for resolution. PACU data: Incidence of laryngospasm, breath-holding, or apnea, presence or absence of nausea/vomiting and if treatment was required, requirement of additional pain medication, documentation of dysphagia prior to the first oral intake and grading of the sore throat as previously documented. Postoperatively, the presence of dysphagia will be sought at two different time points: Via face to face interview in the post operative anesthesia care unit (PACU) prior to the first per oral intake and 24 hours later at which point presence/absence of dysphagia will be ascertained via phone. Complaints will be graded according to a scoring system (Capon LM et al. Anesthesiology 1983) : Presence of sore throat (ST): Yes/No If No, ST will be graded as 0= no sore throat If Yes, ST will be graded 1-3 as follows: 1=mild sore throat (pain with swallowing) 2=moderate sore throat (pain present constantly and worsens with swallowing) 3=severe sore throat (pain interferes with eating and requires analgesic medication for relief). Pain will also be assessed with a VAS score immediately postoperatively and at 24 hours
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal tube | Active comparator | Device: endotracheal tube, Drug: propofol, Drug: Fentanyl, Drug: Dexamethasone, Drug: Ondansetron, Drug: sevoflurane, nitrous oxide and oxygenFollowing routine inhalation induction with 8% sevoflurane in oxygen and nitrous oxide, 100% oxygen will be administered and intravenous access will be secured. Intravenous administration of Propofol 3mg/kg and Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation with an age appropriate endotracheal tube. Presence of an audible air leak around the endotracheal tube will be addressed by inflating the cuff with air until the audible leak is no longer appreciated. The endotracheal tube will not be lubricated prior to intubation. Other medications that will be administered during the procedure include Dexamethasone at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg. |
| No Endotracheal tube | Active comparator | Drug: propofol, Drug: Fentanyl, Drug: Dexamethasone, Drug: Ondansetron, Drug: sevoflurane, nitrous oxide and oxygenThose not receiving endotracheal intubation will undergo an inhalation induction, have intravenous access secured and intravenous propofol 3mg/kg with Fentanyl 1mcg/kg will be administered prior to placement of the nasal trumpet and connection to the anesthesia circuit.patients will receive a general anesthetic consisting of sevoflurane in oxygen and air at routine concentrations for maintenance of anesthesiaOther medications that will be administered during the procedure to both arms of patients include Dexamethasone which will be administered at a dose of 0.15mg/kg up to 20 mg and Ondansetron 0.15mg/kg up to 4mg for post operative nausea and vomiting prophylaxis. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients between the ages of 5-17 with normal cognitive function, without medical comorbidities who are scheduled to undergo esophagogastroduodenoscopy under general anesthesia will be recruited for the study
Key exclusion criteria (3 listed)
- Patients under the age of five, or those between ages 5-17 years with cognitive delay or neurological disease scheduled to undergo Upper GI endoscopy will be excluded.
- Patients who currently have a sore throat or had a sore throat within the past one week will not be included in this study.
- Other patients with cardiopulmonary disease, coagulopathies, hepatorenal disease, endocrinological disease or airway abnormalities will also be excluded.
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 |
|---|---|---|
| endotracheal tubeThis study will determine if the placement of an ETT will lead to dysphagia. | Device | Endotracheal tube |
| propofolpropofol 3mg/kg will be administered to facilitate endotracheal intubation | Drug | Endotracheal tube, No Endotracheal tube |
| FentanylFentanyl 1mcg/kg will be administered to facilitate endotracheal intubation | Drug | Endotracheal tube, No Endotracheal tube |
| DexamethasoneDexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis | Drug | Endotracheal tube, No Endotracheal tube |
| OndansetronOndansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis | Drug | Endotracheal tube, No Endotracheal tube |
| sevoflurane, nitrous oxide and oxygenInhalational agents will be used to induce general anesthesia | Drug | Endotracheal tube, No Endotracheal tube |
Primary outcome
Incidence of Dysphagia
Time frame: up to 24 hours
Dysphagia will be determined by a scale ( 0=no sore throat, 1=mild sore throat, 2=moderate sore throat, 3=severe sore throat) and Visual analog scale .
1 secondary outcome
Patient Satisfaction
Time frame: up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Dysphagia
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.
Imelda M Tjia, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing endotracheal tube, propofol and Fentanyl in people with Dysphagia and Respiratory Complications, run by Baylor College of Medicine.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 Mar 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dysphagia (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.