跳至主要内容
临床试验/CTRI/2025/02/080983
CTRI/2025/02/080983尚未招募不适用

TO EVALUATE THE CHANGE OF MALLAMPATI SCORE WITH INSPIRATION AND EXPIRATION: AN OBSERVATIONAL STUDY

Dr Sambaturu Vedanth1 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2027年3月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
413
试验地点
1
主要终点
To compare the change of Mallampati score during inspiration & expiration

研究概览

简要总结

FOR MALLAMPATI SCORE:

· Keeping the patients tongue protruded ,patients will be instructed to inhale and hold their breath, and inspiration Mallampati score will be obtained.

· Then in the same view, patients will be instructed to exhale and expiration Mallampati score will be  obtained

· The documented Mallampati score with the respiration will be  compared with the baseline Mallampati score documented by the anesthesia team in pac clinic

· Scoring will be  partitioned into 7 categories[8]:

§ WORSE : [ -3,-2,-1]

§ SAME     : [ 0 ]

§ BETTER: [1,2,3]

· For example: If a patients reference Mallampati score was 2, but it was 3 during inspiration , we would score that change as -1.

FOR TMD WITH RESPIRATION:

· Patient will be instructed to extend hisher neck to maximum with the mouth closed .

· And the patient will be  instructed to inhale and hold and the measurement is documented and patient will be instructed to exhale and measurement is documented.

FOR SMD WITH RESPIRATION:

Sternomental distance is measured as they’re mental distance is measured and measurement is document

REFERENCES

1. Hanouz JL, Bonnet V, Buléon C, et al. Comparison of the Mallampati classification in sitting and supine position to predict difficult tracheal intubation: a prospective observational cohort study. Anesthesia & Analgesia *.*2018;126(1):161–9.

2.  Manabe Y, Iwamoto S, Miyawaki H, Seo K, Sugiyama K. Mallampati classification without tongue protrusion can predict difficult tracheal intubation more accurately than the traditional Mallampati classification. Oral Science International . 2014;11(2):52–5.

3. Tham EJ, Gildersleve CD, Sanders LD, Mapleson WW, Vaughan RS. Effects of posture, phonation and observer on mallampati classification. British Journal of Anaesthesia *.*1992;68(1):32–8.

4.  Nuckton TJ, Glidden DV, Browner WS, Claman DM. Physical examination: Mallampati score as an independent predictor of obstructive sleep apnea. Sleep . 2006;29(7):903–8.

5.   Osman AM, Carberry JC, Gandevia SC, Butler JE, Eckert D J. Changes in pharyngeal collapsibility and genioglossus reflex responses to negative pressure during the respiratory cycle in obstructive sleep apnoea. The Journal of Physiology*.*2020;598(3):567–80.

6. Osman AM, Carberry JC, Gandevia S C, Butler J E, Eckert D J. Changes in pharyngeal collapsibility and genioglossus reflex responses to negative pressure during the respiratory cycle in obstructive sleep apnoea. The Journal of Physiology *.*2020;598(3):567–80.

7. Lee A, Fan LTN, Gin T, Karmakar MK, Ngan Kee W D. A systematic review (Meta-Analysis) of the accuracy of the Mallampati tests to predict the difficult airway. Anesthesia and Analgesia *.*2006;102(6):1867–78.

8.  Naftalovich R, Oydanich M, Adeola J, Eloy JD, Rodriguez-Correa D, Tewfik GL. A Prospective Cohort Study on the Respiratory Effect on Modified Mallampati Scoring. Anesthesiol Res Pract. 2023 Aug 23;2023:2193403

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age group between 18 to 65 years scheduled for elective surgery requiring general anaesthesia and endotracheal intubation 2)ASA grading 1 & 2.

排除标准

  • Pregnant women.
  • Obese patients, DM patient, Upper body burns patients.
  • Restricted mouth opening, intraoral pathology (fibrosis, tonsillitis, tumours, dental infections) 4)Patient on radiation therapy, pt with neurological disorders like tetanus, bells palsy.
  • Patient with cervical trauma.

结局指标

主要结局

To compare the change of Mallampati score during inspiration & expiration

时间窗: At inspiration for 5 seconds and expiration for 5 seconds

次要结局

  • To compare the change of THYROMENTAL DISTANCE & STERNOMENTAL DISTANCE with inspiration & expiration.

研究者

发起方
Dr Sambaturu Vedanth
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sambaturu Vedanth

Gauhati Medical College and Hospital

研究点 (1)

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