| CTRI Number |
CTRI/2024/07/069937 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Focused breathing exercises. Nadisuddi, Bhastrika and Pranava Pramayama] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Breathing exercises in prevention of respiratory complications after surgery in lung cancer patients |
|
Scientific Title of Study
|
Focused breathing exercises in prevention of postoperative pulmonary complications in lung cancer patients undergoing lung cancer surgery at tertiary care centre, Mumbai |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Study Protocol Version 3.0, dated 29 May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Prathepa Jagdish |
| Designation |
Professor |
| Affiliation |
College of Nursing, Tata Memorial Hospital, Mumbai |
| Address |
College of Nursing,
Tata Memorial Hospital,
13th Floor, Homi Bhabha Building,
Dr. E. Borges Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869220441 |
| Fax |
|
| Email |
prathepa_jagadish@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Prathepa Jagdish |
| Designation |
Professor |
| Affiliation |
College of Nursing, Tata Memorial Hospital, Mumbai |
| Address |
College of Nursing,
Tata Memorial Hospital,
13th Floor, Homi Bhabha Building,
Dr. E. Borges Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869220441 |
| Fax |
|
| Email |
prathepa_jagadish@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Arvind Borude |
| Designation |
Final Year M.Sc. Nursing Student |
| Affiliation |
College of Nursing, Tata Memorial Hospital, Mumbai |
| Address |
College of Nursing,
Tata Memorial Hospital,
13th Floor, Homi Bhabha Building,
Dr. E. Borges Marg, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9595222543 |
| Fax |
|
| Email |
arvind8494@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Funding, TRAC (Tata Memorial Admin Council), Tata Memorial Centre, D.A.E. Clinical Research Secretariate, 3rd Floor, Main Building, Dr. E. Borges Marg, Parel, Mumbai. 400012. Maharashtra, India. Phone 022 24177000, 24177300, 24161413. Fax 02224146937 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr. E. Borges Marg, Parel, Mumbai. 400012. Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prathepa Jagdish |
Tata Memorial Hospital |
Dr. E. Borges Marg, Parel, Mumbai. Maharashtra, India. 400012
Mumbai
MAHARASHTRA |
9869220441
prathepa_jagadish@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C343||Malignant neoplasm of lower lobe,bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Focused Breathing Exercises. Nadisuddi, Bhastrika and Pranava Pranayama |
Day 1 to Day 3,
All interventions will be taught and demonstrated, and return demonstration will be taken from the participants. Also, the video of exercises will be provided to participants to follow the exercises in same way.
Day 4 to day 2,
Daily interaction will be done on phone call and maintained in log book. Exercises will be supervised and follow up will be taken on daily basis either face to face or video call.
Postoperative day 1 to day 7,
Same exercises will be continued till the postoperative day 7.
From postoperative day 1 to day 7, experimental group will be assessed for the postoperative pulmonary complications using Clavien-Dindo classification system of pulmonary complications and the final result will be recorded.
Data analysis and interpretation will be done with statistics for the final inference.
Investigator is trained to taught interventions.
Log book will be maintained by the investigator. |
| Comparator Agent |
Standard routine treatment and preoperative exercises will be given to participants. |
From postoperative day 1 to day 7, control group will be assessed for the postoperative pulmonary complications using Clavien-Dindo classification system of pulmonary complications and the final result will be recorded.
Data analysis and interpretation will be done with statistics for the final inference.
Log book will be maintained by the investigator. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with NSCLC, carcinoid and pulmonary metastasis, undergoing lung surgery
2) Patients planned for anatomical lung resections (Segmentectomy, Lobectomy, Pneumonectomy, a wedge resection)
3) Patients who are able to practice breathing exercises. |
|
| ExclusionCriteria |
| Details |
1) Patients who have received NACT.
2) Patients with previous history of thoracotomy, Lung resection, CABG, Pulmonary tuberculosis.
3) Patients who have received pulmonary radiation either neoadjuvant or definitive.
4) Patients on treatment for tuberculosis and severe to very severe COPD.
5) Who have undergone psychological / psychiatric treatment and will not be able to follow the instructions / carry out the focused breathing exercises.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To find out the effect of focused breathing exercises by assessment of postoperative pulmonary complications using Clavien-Dindo classification system of pulmonary complications by analysis |
From postoperative day 1 to day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Assess the prevalence of postoperative pulmonary complications in patients undergoing lung cancer surgery.
• Determine the length of hospitalization by the final day of hospitalization.
• Know the association between clinical data and postoperative pulmonary complications by analysis. |
• From postoperative day 1 to day 7.
• Last day of hospitalization. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgical resection for lung cancer offers best chance of cure from the disease, but is mostly associated with a risk of postoperative pulmonary complications. Postoperative pulmonary complications (PPCs) are the major cause of perioperative morbidity and mortality. Postoperative pulmonary complications following lung resection are associated with longer length of hospital stay, higher rate of intensive care unit (ICU) admissions, higher 30-day readmissions, and reduced overall survival. PPCs are responsible for substantially increasing the length of stay of patient in hospital and this length of stay also increases the financial burden of the patient’s family who are already in trouble and put a larger impact on patient’s socioeconomic status. Hence, postoperative pulmonary complications have attracted considerable attention in hospital settings in patients after thoracic surgery and prevention of PPCs is of significant importance. To prevent the occurrence of PPCs, every patient receives postoperative respiratory physiotherapy program as well as early ambulation and lung expansion manoeuvres, including focused deep breathing exercises, incentive spirometry, and airway clearance techniques such as active coughing and sputum expectoration. Focused breathing exercises are used as an alternative treatment in order to combat the dyspnea and improve post operative pulmonary function by teaching patients to utilize more of their lungs. Breathing exercises means elongating and slowing down the inhalation and exhalation, which allow lung cancer patients to take deeper breaths. This increases their intake of oxygen. Exercise before surgery has multiple potential benefits such as improved quality of life, increased pulmonary capacity, endurance, strength and less fatigue with fitness levels before surgery predicting the risk of surgical complications following surgery. The main potential benefit of breathing exercises is to allow air to get right to the bottom of the lungs to help mobilize secretions, by clearing secretions significantly decrease the risk of developing pulmonary complication. In this study, participants need to perform the interventions three times a day for 7 days a week. Investigator wants to know the effect of focused breathing exercises in prevention of postoperative pulmonary complications in lung cancer patients undergoing lung cancer surgery. |