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Clinical Trials/CTRI/2024/10/075590
CTRI/2024/10/075590Not yet recruitingNot Applicable

Performance In 6-Min Walk Test In Prediction Of Postoperative Pulmonary Complication In Major Oncosurgeries And Surgical Gastroentero Surgeries- A Prospective Observational Study

DR S SATHISH KUMAR1 site in 1 country150 target enrollmentStarted: November 1, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
150
Locations
1
Primary Endpoint
To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication).

Study Overview

Brief Summary

The Six minute walk test was introduced for pulmonary evaluation mostly after lung resection surgeries. It is easy to perform, inexpensive and does not need special equipment or trained personnel, hence it is recently included in pre- operative evaluation. It gives an assessment of tolerance of daily activities. Oncology patients have several overlapping factors interfering with exercise capacity and multiple risk factors for post operative pulmonary complications. Changes to the respiratory  system  occur immediately under general anaesthesia. Pulmonary evaluation methods in pre operative period for those at risk are mainly spirometry evaluation of lung function tests ( PFT) and the standard method is cardiopulmonary exercise testing  (CPET). The PFT reports often not reliable as it is influenced by interpretation and patient performance,  while CPET is a complex procedure requiring specialized equipment’s and expertise. Hence alternative methods of functional capacity assessment like 6MWT , incremental shuttle walk test and stair climbing test are useful. **METHODOL****OGY:**After  obtaining  informed  written  consent  all  150  patients  underwent  routine pre operative ,Patients were instructed to walk at their comfortable pace back and forth in the marked track with turn around at either end for a duration of 6 minutes and were informed that they will be allowed to take rest or stop the test incase of discomfort . The test was conducted in a flat , straight hallway 25 metre long where emergency assistance was available along with defibrillator and emergency cart. A stopwatch,  measuring tape, portable pulse oximeter probe ,sphygmomanometer and lap counter Digi Smart Watch were used. The test was stopped if patient experienced any chest pain ,intolerable dyspnea, leg cramps, diaphoresis, pale appearance and medical assistance was given. Before and after the test , the patient’s BP, HR,SPO2 and Borg dyspnea scores were noted. Further the patient’s underwent surgery as planned under general anaesthesia plus epidural anaesthesia and received the routine postoperative care and multi modal analgesia, using epidural analgesia. The occurence of pulmonary complications during post operative period was noted down until discharge from hospital. The PPC included the following: Prolonged mechanical ventilation >48 hours, Atelectasis, Bronchitis, Bronchospasm, ARDS, Pneumonia, Exacerbation of chronic lung disease , respiratory failure.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
60.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • History of cardiovascular or pulmonary diseases.
  • Serum albumin≤30g/L.
  • Chronic smoker and chest X Ray with abnormal lung parenchymal / Chest wall findings.
  • ASA PS-II Or III.

Exclusion Criteria

  • Unstable angina /myocardial infarction/ -Acute coronary syndrome in the previous 6 months -dyspnoea at rest -inability to walk (orthopaedic problems, Cerebrovascular accidents, balance disorders) -unable to interpret or follow instructions, -resting tachycardia(HR ≥120 beats per min/uncontrolled hypertension(BP≥180/100mmofHg).
  • severe pain.

Outcomes

Primary Outcomes

To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication).

Time Frame: To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication) in postoperative 72 hours

Secondary Outcomes

  • To Evaluate(The Incidence Of Complications During 6 Minutes Walk test)
  • To Evaluate Haemodynamics Stability During The Test
  • To Evaluate
  • To evaluate The Impact Of Compounding Factors Like Surgery, Smoking, Respiratory Diseases.
  • To Evaluate(Length Of Hospital Stay)

Investigators

Sponsor
DR S SATHISH KUMAR
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr S SATHISH KUMAR

INSTITUTE OF ANAESTHESIOLOGY,MADURAI MEDICAL COLLEGE

Study Sites (1)

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