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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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
Sharda hospital, plot no 32,34, knowledge park 3, Greater Noida, Uttar Pradesh 201310 
 
Primary Sponsor  
Name  Sharda hospital 
Address  Plot no 32,33, Knowledge park 3, Greater Noida 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
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 
 
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 
 
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" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 
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