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Trial- Dysphagia From ETT or GI Endoscopy

Primary Purpose

Dysphagia, Respiratory Complications

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endotracheal tube
propofol
Fentanyl
Dexamethasone
Ondansetron
sevoflurane, nitrous oxide and oxygen
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphagia focused on measuring EGD Dysphagia, ETT Intubation dysphagia

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Endotracheal tube

    No Endotracheal tube

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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 .

    Secondary Outcome Measures

    Patient Satisfaction
    Patient satisfaction will be measured by a patient satisfaction survey prior to discharge from PACU

    Full Information

    First Posted
    February 27, 2015
    Last Updated
    March 5, 2020
    Sponsor
    Baylor College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460055
    Brief Title
    Trial- Dysphagia From ETT or GI Endoscopy
    Official Title
    Randomized Controlled Trial Examining Effect Of Endotracheal Tube Intubation On Dysphagia In Children Presenting For Upper GI Endoscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no subject met enrollment criteria
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baylor College of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia, Respiratory Complications
    Keywords
    EGD Dysphagia, ETT Intubation dysphagia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Endotracheal tube
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    No Endotracheal tube
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    endotracheal tube
    Intervention Description
    This study will determine if the placement of an ETT will lead to dysphagia.
    Intervention Type
    Drug
    Intervention Name(s)
    propofol
    Intervention Description
    propofol 3mg/kg will be administered to facilitate endotracheal intubation
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Intervention Description
    Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis
    Intervention Type
    Drug
    Intervention Name(s)
    Ondansetron
    Intervention Description
    Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis
    Intervention Type
    Drug
    Intervention Name(s)
    sevoflurane, nitrous oxide and oxygen
    Intervention Description
    Inhalational agents will be used to induce general anesthesia
    Primary Outcome Measure Information:
    Title
    Incidence of Dysphagia
    Description
    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 .
    Time Frame
    up to 24 hours
    Secondary Outcome Measure Information:
    Title
    Patient Satisfaction
    Description
    Patient satisfaction will be measured by a patient satisfaction survey prior to discharge from PACU
    Time Frame
    up to 24 hours
    Other Pre-specified Outcome Measures:
    Title
    Time efficiency with no ETT Intubation
    Description
    Efficiency will be measured by OR times between patients.
    Time Frame
    up to 24 hours
    Title
    Respiratory Compromise
    Description
    Data will be collected for different phases of anesthesia care for episodes of desaturation, laryngospasm, apnea, coughing: induction, intraoperatively and postoperatively.
    Time Frame
    up to 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Imelda M Tjia, MD
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Trial- Dysphagia From ETT or GI Endoscopy

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