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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04665024
Other study ID # 4114.316-474/kk15/2011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date October 1, 2020

Study information

Verified date December 2020
Source University of Pecs
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 1, 2020
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Exclusion Criteria: - Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
preoperative 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.
postoperative 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.

Locations

Country Name City State
Hungary Heart Institute,Medical School, University of Pécs Pécs Pecs

Sponsors (1)

Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in oxygen saturation Sao2 in a day before (zero day) surgery as well as the first seven days of postoperative period.
Primary Change in pulmonary functions FVC and FEV1 At the first seven days of postoperative period
Secondary pulmonary complications pneumonia, atelectasis, phrenic nerve stimulation, ventilator At the first seven days of postoperative period.
Secondary length of hospital staying How many days did the patient stay in the hospital? The minimum stay for the patient is 7 days
See also
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Completed NCT00248898 - Quality of Life After Open Heart Surgery in Older Patients N/A