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CTRI Number  CTRI/2023/05/053197 [Registered on: 29/05/2023] Trial Registered Prospectively
Last Modified On: 25/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   To find if there is any association between diaphragm ultrasound parameters and pulmonary function tests in patients undergoing major abdominal surgeries  
Scientific Title of Study   Association of Diaphragmatic ultrasound parameters with preoperative pulmonary function tests and postoperative respiratory complications in patients undergoing major abdominal surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Puneet Goyal 
Designation  Professor 
Affiliation  SGPGIMS, Lucknow 
Address  Department of Anaesthesiologist, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9918046222  
Fax    
Email  princeofcoma@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Puneet Goyal 
Designation  Professor 
Affiliation  SGPGIMS, Lucknow 
Address  Department of Anaesthesiology,SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9918046222  
Fax    
Email  princeofcoma@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Puneet Goyal 
Designation  Professor 
Affiliation  SGPGIMS, Lucknow 
Address  Department of Anaesthesiology,SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9918046222  
Fax    
Email  princeofcoma@yahoo.co.uk  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
 
Primary Sponsor  
Name  Shreya khatri 
Address  SGPGIMS, Lucknow 
Type of Sponsor  Other [Self] 
 
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 
Shreya Khatri  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow  Department of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road,Lucknow,226014
Lucknow
UTTAR PRADESH 
9108697462

khatrishreya16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K638||Other specified diseases of intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a) Adult patients undergoing major abdominal surgery (Hepatectomy, Whipple’s procedure, Radical cholecystectomy, Transhiatal oesophagectomy, resection and anastomotic surgeries for GI malignancies, Hepatojejunostomy)
b) Age group 18- 60 years
c) ASA I, II, III
d) Cooperative, alert without any major neurological deficit

 
 
ExclusionCriteria 
Details  a) < 18 years and >60 years
b) Preexisting diaphragm paralysis (unilateral or bilateral)
c) ASA IV
d) Major neurological deficit

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate Diaphragmatic excursion, Diaphragmatic thickness (Max inspiration and expiration), Diaphragmatic thickening fraction with preoperative pulmonary function as measured by diaphragmatic ultrasound  preoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Whether preoperative diaphragmatic ultrasound parameters correlate with postoperative respiratory complications  postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   12/06/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Diaphragm is the principal muscle of respiration. Diaphragmatic dysfunction is an underestimated cause of respiratory impairment in postsurgical patients.[1] Abdominal surgeries increase the risk of postoperative diaphragmatic dysfunction.[2] This is purported due to reflex inhibition of phrenic motor output from visceral afferents.[3]

Historically, monitoring for diaphragmatic excursion, diaphragmatic thickness and diaphragmatic thickening fraction has been onerous due to the need for complex equipment and expertise as fluoroscopy, transdiaphragmatic pressure measurement and computerized tomography. Point-of-care ultrasonogram (USG) is a promising modality for real-time monitoring of diaphragmatic excursion, thickness and thickening fraction.

Monitoring preoperative and postoperative respiratory muscle function is at an incipient stage. Diaphragmatic movement correlates well with vital capacity and lung compliance.[7,8]

Ultrasound can be used either to assess motion of the diaphragm dome or changes in diaphragm thickness as it contracts.[5] Ultrasound measures of the diaphragm dome evaluate its effectiveness in displacing the rib cage and abdomen, whereas ultrasound measures of diaphragm thickness in the zone of apposition of the diaphragm to the rib cage (ZOA) allow the clinician to directly assess diaphragm musculature. [5,6]

There are no major studies in the literature which have correlated Diaphragmatic excursion, thickness and thickening fraction with preoperative pulmonary function test and functional capacity of patients undergoing major abdominal surgeries.

The preoperative and postoperative changes in diaphragmatic excursion, thickness and thickening fraction and its correlation with preoperative pulmonary function and postoperative pulmonary complications have not been investigated in major abdominal surgeries.

The aim of this study is to determine whether diaphragmatic excursion, diaphragmatic thickness, diaphragmatic thickening fraction performed in the preoperative period correlate with preoperative pulmonary function test and respiratory reserve of the patients and postoperative pulmonary complications (PPC).

In future this study will help in assessing the diaphragmatic dysfunction and postoperative pulmonary complications.

 

 

Aims and objectives:

Primary aim: To correlate Diaphragmatic excursion, Diaphragmatic thickness (Max inspiration and expiration), Diaphragmatic thickening fraction with preoperative pulmonary function as measured by diaphragmatic ultrasound.

Secondary aim: Whether preoperative diaphragmatic ultrasound parameters correlate with postoperative respiratory complications.

Pulmonary function test of the patients would be performed in the preoperative period on the day before surgery. Following parameters would be recorded-

1)    Breath Holding Time

2)    Vital capacity and Forced vital capacity

3)    Functional residual capacity

4)    Maximum inspiratory capacity

5)    Peak expiratory flow rate

 

 

After this, Diaphragmatic ultrasound would be performed and following parameters would be studied:

a)     Diaphragmatic excursion (left and right hemidiaphragm)

b)    Diaphragmatic thickness(max inspiration and expiration)

c)     Diaphragmatic thickening fraction(left and right hemidiaphragm)

 

 

 

Postoperative respiratory complications if any, would be noted down like respiratory failure requiring ventilatory support in the form of Non-invasive ventilation or mechanical ventilation, no. of days on mechanical ventilation.

Patients will be followed for 72 hours after surgery.

This would end the study protocol.

 

 

 

 

 

 

Sample size:

 

This will be a prospective observational pilot study. We will include all the patients undergoing major abdominal surgeries over a period of one year.


Measurement of Diaphragmatic excursion:

 

Patients would be studied in semi recumbent position between 20° and 40°.

 

For right hemidiaphragm-

With liver as an acoustic window, the probe would be placed immediately below the costal margin in the mid-clavicular line in longitudinal scanning plane with the tomographic plane angled in the cephalad direction such that the ultrasound beam lies perpendicular to the posterior third of the right hemidiaphragm. When the diaphragm is identified with 2-dimensional imaging, the M-mode interrogation line would be adjusted to be perpendicular to the movement of the posterior one-third of the right hemidiaphragm.

For left hemidiaphragm-

With spleen as an acoustic window, the probe would be placed immediately below the costal margin in the mid-clavicular line in longitudinal scanning plane with the tomographic plane angled in the cephalad direction such that the ultrasound beam lies perpendicular to the posterior third of the left hemidiaphragm. When the diaphragm is identified with 2-dimensional imaging, the M-mode interrogation line would be adjusted to be perpendicular to the movement of the posterior one-third of the left hemidiaphragm.

The diaphragm excursion would be measured on the vertical axis of the M-mode tracing (cm) from the beginning.

 

Diaphragmatic thickness would be measured in zone of apposition during both inspiration  and expiration. High frequency linear probe would be placed in 8th or 9th intercostal space between anterior and midaxillary lines and the thickness of the muscle would be measured     at a distance of 0.5-2cm from costophrenic sinus.

 

 

 

Diaphragmatic thickening fraction –

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Outcome assessment: To assess the diaphragmatic parameters (diaphragmatic excursion, diaphragmatic thickness and diaphragmatic thickening fraction) in preoperative period, and its correlation with preoperative pulmonary function test and postoperative pulmonary complications

 

 


 
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