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Inflation-deflation Method for Nasal Intubation in Pediatric Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038762
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Tarek F.Tammam, Suez Canal University

Brief Summary:

Magill forceps is used to maneuver the endotracheal tube ETT in the posterior oropharynx and place its tip into the laryngeal inlet. While the Magill forceps are useful in guiding the nasotracheal tube past the vocal cords, care must be taken to avoid excessive maneuvering in order to minimize the risk of local trauma and rupture of the nasotracheal tube balloon.

Cuff inflation-deflation method can reduce the apnea time in the pediatric patients, a population with known physiological limitations in respiratory reserve. This, in turn, could point to a reduction in the complications (as desaturation and cardiac arrhythmia) that associated with the prolonged-time procedure.


Condition or disease Intervention/treatment Phase
Nasal Intubation Procedure: cuff deflation-inflation -deflation method Not Applicable

Detailed Description:

the investigator will compare the cuff inflation-deflation method versus the conventional method of nasal intubation in pediatric patients for the need of using Magill forceps 90 pediatric patients between the ages of 3 and 12 years with the American Society of Anesthesiologists (ASA) physical status I-II, scheduled for elective surgery (dental and maxillofacial) will be enrolled in a prospectively randomized observer-blinded clinical trial. Patients, who have coagulopathies, have upper airway abnormalities, at risk for aspiration or by reasons of parent's refusal will be excluded from the study.

Airway management is subdivided into phases:

  • Phase 1: Passage of the endotracheal tube through the nose into the pharynx
  • Phase 2: Video-laryngoscope-guided passage of the endotracheal tube through the pharynx into the trachea.

Phase 2 can be performed with the tracheal tube cuff inflation-deflation method vs. non-cuff inflation method. A Magill forceps can be used to guide the endotracheal tube pass through the pharynx and glottis into the trachea if required.

Tracheal tube cuff inflation-deflation method: Tracheal tube cuff is inflated with a variable amount of air (volume of air is depending on the level of the larynx). Once the tip of endotracheal tube at the laryngeal inlet, the cuff of the endotracheal tube is deflated and advanced into the trachea

Patients included in the study will be assigned into two groups for the second phase of airway management:

Group A (n = 45) in whom nasal intubation will be performed using the cuff inflation-deflation method; and Group B (n = 45), in whom the nasal intubation will be performed using non-inflation method.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tracheal Tube Cuff Inflation-deflation Method for Video Laryngoscope-assisted Nasal Intubation in Pediatric Patients
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Active Comparator: Conventional nasal intubation
Passage of an endotracheal tube via the nare followed by video laryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
Procedure: cuff deflation-inflation -deflation method
Nasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
Other Name: pre-cuff inflation

Experimental: Nasotracheal Intubation with cuff inflation-deflation method
Nasotracheal intubation placed with video laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
Procedure: cuff deflation-inflation -deflation method
Nasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
Other Name: pre-cuff inflation




Primary Outcome Measures :
  1. to test whether the inflation-deflation method (pre-cuff inflation) would decrease the need for Magill forceps in video laryngoscopy assisted nasal intubation in pediatric patients compared with the conventional non-cuff inflation approach. T [ Time Frame: during nasal intubation : 60 seconds ]
    The percentage of patients who did not require Magill forceps for nasal intubation success was recorded.


Secondary Outcome Measures :
  1. The time period for the second phase nasal intubation [ Time Frame: 60 seconds ]
    The time in seconds for the second phase nasal intubation

  2. The number of attempts required for successful nasal intubation. [ Time Frame: 120 seconds ]
    number of trials, how many numbers of attempts the investigator take for successful nasal intubation

  3. Amount of injected air for cuff inflation [ Time Frame: 15 seconds ]
    Amount of injected air in ml, how many air injected in the cuff balloon to make the tip of endotracheal tube advanced into the trachea

  4. Assessment of side effects of using Magill forceps during nasal intubation [ Time Frame: Intraoperative and in the first 48 postoperative hours] ]
    A 4-point scale: 1- No epistaxis; 2-Mild epistaxis (blood on the tracheal tube only); 3- Moderate epistaxis (blood pooling in the pharynx); 4- Severe epistaxis (blood in the pharynx sufficient to impede intubation)

  5. Evaluation of oxygenation state during nasal intubation [ Time Frame: preoperative and intraoperative ]
    rate of oxygen drop during the procedure

  6. evaluate the anesthetists' experience of using the inflation-deflation method for nasal intubation. [ Time Frame: 20 minutes after complete recovery of patients ]
    score 1 to 5 A five-point Likert scales for: How likely is it that anesthetist would recommend the same used inflation-deflation method to practice a colleague in the future (not at all/ slightly/ moderately/ very/ extremely: where 1 is not at all, 3 is moderate,5 is extremely



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-II,
  • Scheduled for elective surgery (dental and maxillofacial) in need for nasal intubation.

Exclusion Criteria:

  • Patients, who have coagulopathies,
  • Have upper airway abnormalities,
  • At risk for aspiration or by reasons of
  • Parent's refusal will be excluded from the study

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): NCT04038762


Contacts
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Contact: Tarek F. Tammam, Professor 00201280871947 tarek1367@hotmail.com
Contact: Ghada A. Kamhawy, Lecturer 00201224737320 gkamhawy@yahoo.com

Locations
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Egypt
Tarek F.Tammam Recruiting
Cairo, Egypt, 12311
Contact: Tarek F. Tammam, Professor    00201280871947    tarek1367@hotmail.com   
Contact: Ghada A. Kamhawy, Lecturer    00201224737320    gkamhawy@yahoo.com   
Sponsors and Collaborators
Suez Canal University
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Responsible Party: Tarek F.Tammam, Tarek F.Tammam,M.D,Ph.D,Department of Anesthesia and intendive care,Faculty of Medicine., Suez Canal University
ClinicalTrials.gov Identifier: NCT04038762    
Other Study ID Numbers: Tammam
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No