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Nasopharyngeal Airway Guide Nasogastric Tube Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697642
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
Nasogastric tube placement is essential for various surgery and critically ill patients. However, NG tube insertion in anesthetized, paralyzed, and intubated or unconscious patients may be difficult, with reported success rate less 50% on the first attempt without any auxiliary devices. Endotracheal tube intubation narrow the space of oropharynx and hypopharynx. Loss ability to swallow and tongue drop also made the NG tube coil in the mouth easily. Investigators assume nasopharyngeal airway can facilitate NG tube insertion by opening a channel from nostril to epiglottis and reduce complications by protecting nasal cavity while inserting NG.

Condition or disease Intervention/treatment Phase
Nasogastric Tube Nasopharyngeal Airway Anesthesia, General Procedure: With nasopharyngeal airway Procedure: Without nasopharyngeal airway Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Nasopharyngeal Airway Facilitates Nasogastric Intubation in Anesthetized Intubated Patients: A Randomized Controlled Trial
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : September 3, 2019
Actual Study Completion Date : September 3, 2019

Arm Intervention/treatment
Experimental: NG tube placement with nasopharyngeal tube Procedure: With nasopharyngeal airway
Nasopharyngeal airway is previously inserted into selected nostril. NG tube is properly lubricated and placed through Nasopharyngeal airway.

Active Comparator: NG tube placement without nasopharyngeal tube Procedure: Without nasopharyngeal airway
NG tube is properly lubricated and placed into selected nostril




Primary Outcome Measures :
  1. First attempt successful rate [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance

  2. Second attempt successful rate [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance

  3. Overall successful rate insertion [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance

  4. Time cost during NG tube placement [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance


Secondary Outcome Measures :
  1. Incidence of NG tube coiling [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance during NG tube insertion

  2. Incidence of NG tube kinking [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance during NG tube insertion

  3. Incidence of NG tube knotting [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance during NG tube insertion

  4. Incidence of epistaxis after NG tube placement [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance during NG tube insertion

  5. Mean blood pressure change after NG tube placement [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance

  6. Heart rate change after NG tube placement [ Time Frame: can be know after NG tube placement immediately ]
    with or without Nasopharyngeal airway assistance



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient should be > 20 years old, ASA 1~3 under going schedule general anesthesia with endotracheal tube intubation
  • Patient who required NG tube placement for perioperative care

Exclusion Criteria:

  • Coagulation abnormality (PLT≤100000, INR>1.2 & PT≥13)
  • Hemodynamic unstable (with inotropic agent use)
  • Arrythmia
  • Esophageal varices or stricture, Esophageal cancer, trauma or previous esophageal surgery
  • Gastric cancer involve cardiac orifice
  • Corrosive chemical (strong acid or alkali) ingestion
  • Skull base fracture
  • Recent nasal surgery, nasal fracture or severe nasal obstruction
  • Loose teeth that make endotracheal tube can not fix right side

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697642


Locations
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Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 10507
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03697642    
Other Study ID Numbers: 201800138A3
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes