Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery

NCT06378073 | Active Not Recruiting DMC

• 1 other identifier: DPT/Batch-Fall19/557
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 5

Brief Summary

"A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups. In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS"

Conditions

Surgery-Complications

Outcome Measures

Primary Outcomes (2)

• Incentive Spirometer

  A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) Specificity: The diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS \> 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS \> 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments.

  6 Month

• Incentive Spirometer

  Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications.

  6 Months

Study Arms (2)

Incentive Spirometer

EXPERIMENTAL

Diagnostic Test: Incentive Spirometer

Numeric Pain Rating Scale

OTHER

Diagnostic Test: Numeric Pain Rating Scale

Interventions

Incentive Spirometer DIAGNOSTIC_TEST

Specificity and sensitivity: Incentive spirometry is a specific type of spirometry that aims to encourage people to breathe deeply intentionally but does not provide a measurement or inform management of chronic lung diseases. Less than 5 repetitions per day (sensitivity 93%, specificity 77%) and less than 2 balls per repetition (sensitivity 93%, specificity 77%) were predictive of postoperative pulmonary complications. (1) Validity and reliability: Incentive spirometry can be used as a simple mean to follow lung function, especially VC, in the postoperative period in spontaneously breathing patients. Incentive spirometry is noninvasive and can be performed repeatedly at the bedside in the intensive care setting. (2) Interpretation: There are only three numeric values that are required to interpret spirometry: * Forced Vital Capacity (FVC) * Forced Expiratory Volume (FEV1) * FEV1/FVC ratio.

Incentive Spirometer

Numeric Pain Rating Scale DIAGNOSTIC_TEST

Sensitivity: The area under the receiver operator characteristic curve for the NRS as a test for pain that interferes with functioning was 0.76, indicating fair accuracy. A pain screening NRS score of 1 was 69% sensitive for pain that interferes with functioning. (4) he diagnostic value of different NRS cut-off values for administering analgesics is determined by an ROC curve. Sensitivity of NRS \> 3 for 'unbearable' pain in older patients was 72% with a specificity of 97·2%. With a cut-off point NRS \> 4, sensitivity increased to 83%, while specificity was 96·7%. (5) Validity and reliability: The numerical rating scale is a reliable and valid tool for pain assessment in patients with musculoskeletal impairments. (3) Measurement (circle): Categorical /Numerical /Both: Numerical: The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Numeric Pain Rating Scale

Eligibility Criteria

• Age: 48 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing in Cardiac Surgery like, CABG, univalve, bivalve and trivalve.

You may not qualify if:

• Valve and CABG surgery combined with other cardiac surgery like percutaneous valve replacement.
• Cognitive disorder of the heart.

Sponsors & Collaborators

• Superior University: lead

Study Sites (5)

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

Bahria Hospital

Lahore, Punjab Province, Pakistan

Location

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Location

Punjab Institute of Cardiology Hospital

Lahore, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: April 5, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (5)