Trial- Dysphagia From ETT or GI Endoscopy
Randomized Controlled Trial Examining Effect Of Endotracheal Tube Intubation On Dysphagia In Children Presenting For Upper GI Endoscopy
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Phase
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Endotracheal tube
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.
|
This study will determine if the placement of an ETT will lead to dysphagia.
propofol 3mg/kg will be administered to facilitate endotracheal intubation
Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation
Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis
Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis
Inhalational agents will be used to induce general anesthesia
|
|
Active Comparator: No Endotracheal tube
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.
|
propofol 3mg/kg will be administered to facilitate endotracheal intubation
Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation
Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis
Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis
Inhalational agents will be used to induce general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
|
up to 24 hours
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction
Time Frame: up to 24 hours
|
Patient satisfaction will be measured by a patient satisfaction survey prior to discharge from PACU
|
up to 24 hours
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time efficiency with no ETT Intubation
Time Frame: up to 24 hours
|
Efficiency will be measured by OR times between patients.
|
up to 24 hours
|
|
Respiratory Compromise
Time Frame: up to 24 hours
|
Data will be collected for different phases of anesthesia care for episodes of desaturation, laryngospasm, apnea, coughing: induction, intraoperatively and postoperatively.
|
up to 24 hours
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Imelda M Tjia, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Deglutition Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Platelet Aggregation Inhibitors
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dermatologic Agents
- Analgesics, Opioid
- Narcotics
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- Anesthetics, Inhalation
- Antipruritics
- Dexamethasone
- Fentanyl
- Propofol
- Sevoflurane
- Nitrous Oxide
- Ondansetron
Other Study ID Numbers
Other Study ID Numbers
- H-32691
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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