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CompletedNCT04665024Updated Dec 11, 2020

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

An interventional study of preoperative chest physiotherapy and postoperative chest physiotherapy in Open Heart Surgery Patients, sponsored by University of Pecs. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-11.

Sponsored by University of Pecs · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Apr 2018, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The research was lasted four months in outpatient clinic, cardiothoracic surgical department and intensive care unit at University of Pécs, Clinical Centre, Heart Institute, Hungary . A convenient sample of 100 patients were divided into two groups: group 1 and 2. Group 1 (G1) included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation, and group 2 (G2) included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home. Preoperative and postoperative chest physiotherapy was performed in G1, and only postoperative one made in G2. Potential effects of preoperative chest physiotherapy were studied in both groups with respect to oxygen saturation, pulmonary complications and length of hospital staying. O2 saturation,O2 supplementation, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) were all measured in a day before (zero day) surgery as well as the first seven days of postoperative period.

Results: Measures of oxygen level and lung functions were significantly (P\<0.05) changed in studied groups. The mean values of O2 saturation and supplementation measured in almost seven days of postoperative period were significantly (p\<0.05) higher among G1 compared to the values of G2. The same trend was also correct for the mean values of FVC and FEV1.

Conclusions: The results concluded that, the performance of preoperative chest physiotherapy before open heart surgery is recommended, as it might result in the decrease of complications of heart surgery, improvement of respiratory functions and length of staying at hospital.

02

Conditions studied

  • Open Heart Surgery Patients

Keywords

  • Open heart surgery, chest physiotherapy, spirometry
03

In context

Lead sponsor

University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Group 1

    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

  • Active comparator
    Group 2

    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

  • Procedurepreoperative chest physiotherapy

    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.

  • Procedurepostoperative chest physiotherapy

    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.

06

What researchers measure

Primary outcomes

  1. Change in oxygen saturation

    Sao2

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

  2. Change in pulmonary functions

    FVC and FEV1

    Time frame: At the first seven days of postoperative period

Secondary outcomes

  1. pulmonary complications

    pneumonia, atelectasis, phrenic nerve stimulation, ventilator

    Time frame: At the first seven days of postoperative period.

  2. length of hospital staying

    How many days did the patient stay in the hospital?

    Time frame: The minimum stay for the patient is 7 days

07

Study locations

1 site
  • Heart Institute,Medical School, University of Pécs
    Pécs, Pecs H-7621, Hungary
08

References and documents

Publications

  • 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. PubMed 35112592 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04665024
Lead sponsor
University of Pecs
Responsible party
Sponsor
First posted
Dec 11, 2020
Start date
Apr 1, 2018
Primary completion
Sep 30, 2019
Completion
Oct 1, 2020
Last update
Dec 11, 2020

Study contacts

VERZAR 7- ZSOFIA, Doctor
study director · University of Pecs

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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