Effect of Preoperative Chest Physiotherapy on Lung Functions Among Open Heart Surgery Patients

NCT04665024 | Completed DMC

• 1 other identifier: 4114.316-474/kk15/2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative respiratory complications in patients who had chest-opening heart surgery are considered one of the serious factors threatening their life. However, these potential complications could be minimized using proper preoperative chest physiotherapy. This study was designed to assess the potential effects of using preoperative chest physiotherapy on oxygenation and lung functions among open heart surgery patients during postoperative period.

Conditions

Open Heart Surgery Patients

Keywords

Open heart surgery, chest physiotherapy, spirometry

Outcome Measures

Primary Outcomes (2)

• Change in oxygen saturation

  Sao2

  in a day before (zero day) surgery as well as the first seven days of postoperative period.

• Change in pulmonary functions

  FVC and FEV1

  At the first seven days of postoperative period

Secondary Outcomes (2)

• pulmonary complications

  At the first seven days of postoperative period.

• length of hospital staying

  The minimum stay for the patient is 7 days

Study Arms (2)

Group 1

ACTIVE COMPARATOR

G1 included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation pre and postoperative chest physiotherapy was performed in G1. The chest physiotherapy included the following steps 1. Snipping through the nose several times, then breathe out through the mouth 2. Taking a deep breath through the nose, hold the air in, push it down in the stomach, than back to the chest, and in the end breath out through the mouth 3. Put both hands on the shoulders. Lift the elbows to the sides and take a deep breath through the nose, then lower them, breathe out through the mouth. This procedure was done for the other side as well. 4. Put both hands on your hips. Lift your right arm to the side, turn backwards with it and take a deep breath through the nose, then turn back, put your hand back to the hip and breathe out through the mouth.This procedure was done for the other side as well

Procedure: preoperative chest physiotherapy; Procedure: postoperative chest physiotherapy

Group 2

ACTIVE COMPARATOR

G2 included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home.only postoperative chest physiotherapy made in G2. The patient was seen on the first day after surgery in the intensive care unit and was asked if he had performed breathing exercises at home before surgery and then re-evaluation of both groups with respect to respiratory functions and oxygen saturation values from the first day until the seventh after surgery. Also, a daily chest physical therapy program was introduced in accordance with the hospital's policy until the patient's discharge. Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy mentioned above but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days. The exercises were repeated 10 times and performed 3-4 times per day.

Procedure: postoperative chest physiotherapy

Interventions

preoperative chest physiotherapy PROCEDURE

The patients were approached to partake in the investigation after they got full clarifications about the point of study. They were allocated into two groups and reassurance was achieved about the absence of any side effects.Furthermore, the examination was approved by the ethical committee. Effects of preoperative chest physiotherapy were compared between two groups, by measuring the lung functions, oxygen saturation, pulmonary complications and length of hospital staying. Lung functions were completed by utilizing spirometry parameters, oxygen saturation was measured by pulse oximeter and pulmonary complications were diagnosed by specialist doctors.

Group 1

postoperative chest physiotherapy PROCEDURE

Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days.

Group 1; Group 2

Eligibility Criteria

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

You may not qualify if:

• Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Heart Institute,Medical School, University of Pécs

Pécs, Pecs, H-7621, Hungary

Location

Related Publications (1)

• Shahood H, Pakai A, Rudolf K, Bory E, Szilagyi N, Sandor A, Zsofia V. The effect of preoperative chest physiotherapy on oxygenation and lung function in cardiac surgery patients: a randomized controlled study. Ann Saudi Med. 2022 Jan-Feb;42(1):8-16. doi: 10.5144/0256-4947.2022.8. Epub 2022 Feb 3.

  PMID: 35112592 DERIVED

Study Officials

• VERZAR 7- ZSOFIA, Doctor

  University of Pecs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 11, 2020
• Study Start: April 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 1, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

HU (1)