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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03310866
Other study ID # R/17.08.102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2017
Est. completion date July 30, 2018

Study information

Verified date October 2018
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During fiberoptic endotracheal intubation, the perfect airway exposure produced by the classic curved Macintosh laryngoscope in place of head tilt -chin lift-jaw thrust maneuver may increase the accuracy and produce rapid direct vocal cord access in a short time under Inhalation anesthesia to maintain the respiratory drive for grade III&VI Modified Mallampati .


Description:

Managing difficult airway is critical for anesthesia-related morbidity and mortality. Fiberoptic laryngoscope is a reliable tool for endotracheal intubation in difficult airway cases (Modified Mallampatti III&IV), but always there is difficulty to visualize the glottis due to airway tendency to collapse, classically a specific fiberoptic airway with a side way is used and it may added head tilt chin lift jaw thrust. A new technique utilizing sevoflurane anesthesia to maintain the respiratory drive without exposing the patient to the stress of the awake airway instrumentation. Simultaneous utilization of both Macintosh curved laryngoscope and Fiberoptic bronchoscope during Endotracheal intubation (ETT) will be examined for the efficacy during difficult airway management.

All patients should be examined preoperatively for the scoring Modified Mallampati or non tongue protrusion mallampati (NT-MMT) airway score. The pharyngeal structures were then evaluated and the best view (lowest class) was recorded. The classification follows m-MMT and is as follows: class 1, full visibility of tonsils, uvula, and soft palate; class 2, visibility of hard and soft palate, upper portion of tonsils and uvula; class 3, visibility of the soft and hard palate and base of the uvula; and class 4, visibility of only the hard palate, class III or IV patients were included in the study. Inhalational anesthesia use maintains the respiratory drive of the patient allowing less stressful technique.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 30, 2018
Est. primary completion date July 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult patients with Modified Mallampati (NT-MMT) airway score III,VI

- American Society of Anaesthesiologists (ASA) physical class I-III

- Scheduled for elective cancer surgery under general anesthesia

Exclusion Criteria:

- Modified Mallampati I,II Airway scored patients.

- History of upper airway surgery.

- Patients with serious deformities of the mandible, maxilla, tongue, pharynx or larynx.

- Patients with a history of significant cardiac and pulmonary diseases,

- Obesity with BMI >40,

- Epilepsy, pregnancy, mental disease, neurological psychological disorders.

- Communication barrier.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
fiberoptic, airway
classic fiberoptic bronchoscope, fenstrated airway
fiberoptic, Machintosh
oral fiberoptic brochoscopic, Machintosh laryngoscope

Locations

Country Name City State
Egypt Oncolgy Center, Mansoura University, Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary intubation time time from introduction of the tip of the fiber optic laryngoscope till insertion of the tube in the laryngeal inlet down in the trachea in seconds. during intubation
Secondary lower jaw relaxation (Relaxed= 0, not fully=1, poor= 2) during intubation
Secondary Vocal cord position (Abducted= 0, Intermediate opening= 1, Closed= 2) during intubation
Secondary Neck movements for endotracheal tube or cuff inflation (no=0, slight= 1, vigorous= 2), during intubation and cuff inflation
Secondary Cough (absent= 0, present=1) during intubation and cuff inflation
Secondary 1st trial success rate in percent during intubation
Secondary the number of trails (1st trial=1, 2nd trial= 2, 3rd trial= 3) during intubation
Secondary mean arterial Blood pressure (MBP) basal, every minute during intubation, 1, 3, 5 minutes after intubation during intubation till 5 minutes after intubation
Secondary mean heart rate (HR) basal, every minute during intubation, 1, 3, 5 minutes after intubation during intubation till 5 minutes after intubation
Secondary desaturation (SpO2) oxygen saturation <90% .(Yes=1, No= 0) during intubation
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