Open Heart Surgery PatientsNCT04665024
Effect of Preoperative Chest Physiotherapy on Lung Functions Among Open Heart Surgery Patients
A study testing preoperative chest physiotherapy and postoperative chest physiotherapy in people with Open Heart Surgery Patients, run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Heart Surgery Patients
- What is being tested?
- preoperative chest physiotherapy and postoperative chest physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Heart Institute,Medical School, University of Pécs
Pécs, Pecs, H-7621
About this study
Official title: The Effect of Preoperative Chest Physiotherapy on Oxygenation and Lung Functions Among Open Heart Surgery Patients
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.
- Conditions
- Open Heart Surgery Patients
- Being tested
- preoperative chest physiotherapy, postoperative chest physiotherapy
- Keywords
- Open heart surgery, chest physiotherapy, spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative chest physiotherapyProcedure or surgery
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.
postoperative chest physiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: postoperative chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxygen saturation
Sao2
Measured: in a day before (zero day) surgery as well as the first seven days of postoperative period.
Change in pulmonary functions
FVC and FEV1
Measured: At the first seven days of postoperative period
Secondary outcomes (2)
pulmonary complications
pneumonia, atelectasis, phrenic nerve stimulation, ventilator
Measured: At the first seven days of postoperative period.
length of hospital staying
How many days did the patient stay in the hospital?
Measured: The minimum stay for the patient is 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Apr 2018
- Primary completion30 Sep 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Heart Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VERZAR 7- ZSOFIA, Doctor, Study director, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665024
- Sponsor's protocol ID
- 4114.316-474/kk15/2011
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Chest Physiotherapy on Oxygenation and Lung Functions Among Open Heart Surgery Patients
- ClinicalTrials.gov ID
- NCT04665024
- Acronym / sponsor ID
- 4114.316-474/kk15/2011
- Conditions
- Open Heart Surgery Patients
- Keywords
- Open heart surgery, chest physiotherapy, spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: preoperative chest physiotherapy, Procedure: postoperative chest physiotherapyG1 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 |
| Group 2 | Active comparator | Procedure: postoperative chest physiotherapyG2 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative chest physiotherapyThe 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. | Procedure or surgery | Group 1 |
| postoperative chest physiotherapyPostoperative 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. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Change in oxygen saturation
Time frame: in a day before (zero day) surgery as well as the first seven days of postoperative period.
Sao2
Change in pulmonary functions
Time frame: At the first seven days of postoperative period
FVC and FEV1
2 secondary outcomes
pulmonary complications
Time frame: At the first seven days of postoperative period.
length of hospital staying
Time frame: The minimum stay for the patient is 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Derived from this study: PubMed 35112592Shahood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VERZAR 7- ZSOFIA, Doctor study director
University of Pecs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative chest physiotherapy and postoperative chest physiotherapy in people with Open Heart Surgery Patients, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oxygen saturation (time frame: in a day before (zero day) surgery as well as the first seven days of postoperative period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.