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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dysphagia; Respiratory Complications
• Intervention / Treatment: Device: endotracheal tube; Drug: propofol; Drug: Fentanyl; Drug: Dexamethasone; Drug: Ondansetron; Drug: sevoflurane, nitrous oxide and oxygen

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

2

Arms and Interventions

Participant Group / Arm	Intervention / 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.	Device: endotracheal tube; This study will determine if the placement of an ETT will lead to dysphagia.; Drug: propofol; propofol 3mg/kg will be administered to facilitate endotracheal intubation; Drug: Fentanyl; Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation; Drug: Dexamethasone; Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis; Drug: Ondansetron; Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis; Drug: sevoflurane, nitrous oxide and oxygen; 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.	Drug: propofol; propofol 3mg/kg will be administered to facilitate endotracheal intubation; Drug: Fentanyl; Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation; Drug: Dexamethasone; Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis; Drug: Ondansetron; Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis; Drug: sevoflurane, nitrous oxide and oxygen; Inhalational agents will be used to induce general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction will be measured by a patient satisfaction survey prior to discharge from PACU	up to 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time efficiency with no ETT Intubation	Efficiency will be measured by OR times between patients.	up to 24 hours
Respiratory Compromise	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: Baylor College of Medicine
• Investigators: Principal Investigator: Imelda M Tjia, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: EGD Dysphagia; ETT Intubation dysphagia
• 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: H-32691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided