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

NCT ID: NCT06378073

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2024-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

"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"

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery-Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Incentive Spirometer

Group Type EXPERIMENTAL

Incentive Spirometer

Intervention Type 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.

Numeric Pain Rating Scale

Group Type OTHER

Numeric Pain Rating Scale

Intervention Type 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")

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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. (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.

Intervention Type DIAGNOSTIC_TEST

Numeric Pain Rating Scale

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")

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Valve and CABG surgery combined with other cardiac surgery like percutaneous valve replacement.
* Cognitive disorder of the heart.
Minimum Eligible Age

48 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Superior University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Site Status

Bahria Hospital

Lahore, Punjab Province, Pakistan

Site Status

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

Lahore, Punjab Province, Pakistan

Site Status

The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status

Punjab Institute of Cardiology Hospital

Lahore, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DPT/Batch-Fall19/557

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.