| CTRI Number |
CTRI/2022/09/045200 [Registered on: 05/09/2022] Trial Registered Prospectively |
| Last Modified On: |
18/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Difficult intubation can be known beforehand in ICU patients using MACOCHA score |
|
Scientific Title of Study
|
Prediction of difficult tracheal intubation in ICU patients using MACOCHA score |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepanshi |
| Designation |
Pg 1st year Anaesthesia |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anaesthesiology, School of medical sciences and research, plot no 32,34 Knowledge park 3 Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
8860223060 |
| Fax |
|
| Email |
deepanshi1901@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ram Murti Sharma |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anaesthesiology, School of medical sciences and research, plot no 32,34 Knowledge park 3 Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
7798881243 |
| Fax |
|
| Email |
sharmarammurti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ram Murti Sharma |
| Designation |
Professor |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anaesthesiology, School of medical sciences and research, plot no 32,34 Knowledge park 3 Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
7798881243 |
| Fax |
|
| Email |
sharmarammurti@gmail.com |
|
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Source of Monetary or Material Support
|
| Sharda hospital, plot no 32,34, knowledge park 3, Greater Noida, Uttar Pradesh 201310 |
|
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Primary Sponsor
|
| Name |
Sharda hospital |
| Address |
Plot no 32,33, Knowledge park 3, Greater Noida |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepanshi |
Sharda hospital, school of medical sciences and research |
Department of Anaesthesiology, 2nd floor ICU Gautam Buddha Nagar UTTAR PRADESH |
8860223060
deepanshi1901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender requiring endotracheal intubation in ICU for mechanical ventilation.
Age above 18 years |
|
| ExclusionCriteria |
| Details |
obstetric patients
non consenting patients and patients attendant
cardiac arrest patients needing urgent tracheal intubation |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate MACOCHA score in ICU patients for tracheal intubation and correlate with Cormack-Lehane grade during laryngoscopy |
15 mins |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To study complications in patients with high MACOCHA score
To study factors contributing towards physiological difficult airway such as shock and acidosis |
12hours |
|
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Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Endotracheal intubation is a commonly performed procedure in the intensive care unit (ICU) for patients requiring ventilatory support. Non-elective intubation of critically ill patients in ICU is associated with a high rate of peri-procedural morbidity and mortality (1). A critical situation may be caused by lack of operator skills or patient factors such as shock, acidosis, hypoxemia due to acute respiratory failure and loss of consciousness causing a high risk for aspiration which requires rapid establishment of secured airways (2). A large number of tests and scores such as LEMON, Wilson score, and mandibular protrusion test have been used for assessment of airway for patient requiring general anesthesia with endotracheal intubation. However only test available for assessing airway in ICU patients requiring mask ventilation and endotracheal intubation is MACOCHA score developed by De Jong (3) is one test used for ICU patients. Seven clinical items available in the ICU were identified as independent risk factors for difficult intubation and constituted the MACOCHA score established by de Jong. The ‘MACOCHA’ score calculation includes patient characteristics: Mallampati score III or IV, Apnea syndrome (obstructive), Cervical spine limitation, Opening mouth < 3cm, Coma, Hypoxia, Anesthesiologist nontrained. Higher score levels particularly at the maximum levels (12 points) were associated with extremely difficult intubation and complications (3). In ICU patients Mallampati score alone is less effective than MACOCHA score to predict difficult intubation. Two factors specific to ICU patients were recognized in this study and are included in the score: severe hypoxemia before intubation and coma (Glasgow score 8 as a reason for intubation). Severe hypoxemia as a risk factor can be explained by a shortness of time to be adequately prepared for the intubation and perhaps by increased stress for physicians performing the procedure. Likewise, patients intubated for coma often present increased oropharyngeal secretions, limiting view of the glottis. The MACOCHA score is highly reliable tool to identify those patients in whom the failure rate of non-anaesthesiologist was 100%. It is a convincing finding that a definitive failure seems to be predictable. The MACOCHA score is a simple tool, which can be performed within a very short time period and seems to be superior to Mallampati classification (2). Early identification of risk factors for difficult intubation could allow for anticipation and preparation of adequate material, use of an alternative intubation strategy, and call on additional assistance before intubation and thus reduce morbidity. Difficult intubation was defined as three or more laryngoscopic attempts to place the endotracheal tube into the trachea or as lasting more than 10 minutes using conventional laryngoscopy (4). The MACOCHA score enables patients at risk of difficult intubation to be identified and further reduce the incidence of difficult intubations and related complications (5). Most of the patients in ICU may need endotracheal intubation because of hypoxia caused by acute respiratory failure and/or loss of consciousness due to neurological cause, and cardiogenic or septic shock. Neither the reason of admission nor the underlying reasons for Endotracheal intubation is predictors for difficult airway management. All patients in ICU requiring endotracheal intubation and mechanical ventilation will be included in the study. Macocha Score grading will be compared with laryngeal view during direct laryngoscopy. The Cormack-Lehane classification is a grading system commonly used to describe laryngeal view during direct laryngoscopy. With this scale, a grade I view connotes a full view of the entire glottic aperture, grade II represents a partial glottic view, grade III represents visualization of the epiglottis only, and grade IV represents inability to visualize even the epiglottis |