Laparotomy PatientsNCT04913428
Breathing Exercises for Pulmonary Function of Post-laparotomy Patients .
A study testing Interdigital exercise and Blow-Bottle technique in people with Laparotomy Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study is designed to compare the effects of blow bottle technique and interdigital exercises on the pulmonary functions of the post laparotomy patients where there is sudden decline in lung function and increased rate of complications after the surgery. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Laparotomy Patients
- What is being tested?
- Interdigital exercise and Blow-Bottle technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Mar 2018to 20 Sep 2018
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Post laparotomy patients
- Age 25 to 45 years.
- Both genders.
Who cannot join
- Vitally unstable patients
- Complicated laparotomies
- Patients with post-operative complications e.g. delirium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Blow-bottle Technique and Interdigital Breathing for Pulmonary Function of Post-laparotomy Patients .
The study is designed to compare the effects of blow bottle technique and interdigital exercises on the pulmonary functions of the post laparotomy patients where there is sudden decline in lung function and increased rate of complications after the surgery. A randomized control trial was conducted including post laparotomy patients, randomly allocated to interventional and control groups. Both the groups received breathing exercises along with conventional treatment during phase I rehabilitation. Data was collected at baseline, before and after every session and after 6 sessions before patient discharge from hospital. Outcome measures include assessment of lung volumes and capacities, oxygen saturation and vitals of the post laparotomy patients
Read the detailed description
Pulmonary complications are common in post laparotomy patients because of multiple pre operative, intra operative and post operative factors. To manage these complications many interventions and breathing techniques are used. These complications alter the pulmonary function leading to decreased chest expansion, oxygen saturation and post operative atelectasis. Anesthetic drugs that also cause cardiac depression along with hemodynamic instability of the patient. Incision given to the chest or abdominal wall during procedure causes to lose the integrity of respiratory muscles which effects the functions of the muscle directly. Respiratory muscles are compromised, normal lung volumes are depressed. More than 75% of patients who are receiving neuromuscular blocking agent develops atelectasis. The estimated time after surgery for patient to return to its preoperative health status is approximately 6 weeks. These complications increase the hospital length of stay and cost associated with it as well as increase the morbidity and mortality.
Lung expansion techniques (LETs) are widely used to prevent postoperative pulmonary complications (PPCs). However, the effects of each of these techniques on thoraco-abdominal mechanics and PPC incidence after abdominal surgery remain unclear. Active Cycle of Breathing Techniques (ACBT) has shown to be effective in mobilizing and clearing the excess bronchial secretions and to improve lung function. It neither causes nor increases hypoxemia or increases airflow obstruction. Chest physiotherapy and breathing exercises are often prescribed to patients undergoing cardiac surgery and abdominal surgery in order to prevent or reduce post-operative pulmonary complications. There are different breathing techniques with and without mechanical devices after the surgery, but there is controversy regarding which breathing techniques are the most effective.
Researches have proved change in pulmonary functions by the use of various breathing exercises. Depressed pulmonary functions i.e. decreased forced vital capacity (FVC) , decreased forced expiratory volume (FEV1), Peak Expiratory Flow Rate (PEFR) are seen as result of disturbed lung function. Alteration in function of diaphragm contributes in postoperatively pulmonary function disturbances. Chest physiotherapy is implied for minimizing the altered lung functions and complications. This includes multiple breathing exercises, percussion , vibrations, huffing, coughing techniques, postural drainage and mobilization.
The current study is conducted to compare two respiratory techniques for the improvement in post operative pulmonary function; because of incisional pain, patients find the inspiratory exercises difficult to perform, therefore, the study is conducted to assess if easy-to -perform expiratory techniques are similar in effect to the inspiratory techniques and for the said purpose comparison of blow bottle technique and interdigital breathing on post laparotomy patients is made for the improvement of pulmonary function and vitals of these patients.
.
- Conditions
- Laparotomy Patients
- Being tested
- Interdigital exercise, Blow-Bottle technique
- Keywords
- Pulmonary function, Chest expansion, Laparotomy, Spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdigital exerciseOther
Patient asked to sit in upright position interlocking their fingers with inhaling deeply bringing the arms up and exhaling through mouth while bring the arm down.
Blow-Bottle techniqueOther
For blow bottle 20cm of bottle filled with 10cm of water in which a tube of length 35- 40cm inserted with the inner diameter of ≥8mm(21).Patient is asked to form bubbles in bottle by exhaling in bottle performing Forced Expiratory Techniques.
| Study group | Role | What they receive |
|---|---|---|
| Interdigital exercise group | Experimental | Interdigital exercises:
12 repetitions in 3 sets of 4 repetitions
Conventional Physical Therapy:
Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes Receives: Other: Interdigital exercise |
| Blow-Bottle technique group | Active comparator | Blow-Bottle technique:
12 repetitions in 3 sets of 4 repetitions
Conventional Physical Therapy:
Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes Receives: Other: Blow-Bottle technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow rate (PEFR)
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Measured: 5 days
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Measured: 5 days
Forced expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
Measured: 5 days
FVC/FEV1
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Measured: 5 days
Secondary outcomes (4)
Oxygen Saturation (SPO2)
Oxygen saturation measured through pulse oximeter as part of vitals
Measured: 5 days
Heart rate
Heart rate is measured as part of vitals through heart rate monitor.
Measured: 5 days
Chest expansion
Chest expansion at xiphoid level measured by finding the difference in measurements during inhalation and exhalation.
Measured: 5 days
Respiratory rate
Respiratory rate calculated standing at bedside of patient.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start30 Mar 2018
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Laparotomy 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913428
- Sponsor's protocol ID
- REC/00313 Huda Anjum
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon B, Laffargue F. Pfannenstiel versus Maylard incision for cesarean delivery: A randomized controlled trial. Obstet Gynecol. 2002 May;99(5 Pt 1):745-50. doi: 10.1016/s0029-7844(02)01957-9.
PubMed 11978282Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PubMed 28186222Dagan Y, Wiser I, Weissman O, Farber N, Hundeshagen G, Winkler E, Kazula-Halabi T, Haik J. An Improvised "Blow Glove" Device Produces Similar PEP Values to a Commercial PEP Device: An Experimental Study. Physiother Can. 2014 Summer;66(3):308-12. doi: 10.3138/ptc.2013-31.
PubMed 25125786Alaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.
PubMed 27525116Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
PubMed 7006464Agostini P, Naidu B, Cieslik H, Steyn R, Rajesh PB, Bishay E, Kalkat MS, Singh S. Effectiveness of incentive spirometry in patients following thoracotomy and lung resection including those at high risk for developing pulmonary complications. Thorax. 2013 Jun;68(6):580-5. doi: 10.1136/thoraxjnl-2012-202785. Epub 2013 Feb 21.
PubMed 23429831Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
PubMed 25607594Lunardi AC, Paisani DM, Silva CCBMD, Cano DP, Tanaka C, Carvalho CRF. Comparison of lung expansion techniques on thoracoabdominal mechanics and incidence of pulmonary complications after upper abdominal surgery: a randomized and controlled trial. Chest. 2015 Oct;148(4):1003-1010. doi: 10.1378/chest.14-2696.
PubMed 25973670Westerdahl E, Lindmark B, Almgren SO, Tenling A. Chest physiotherapy after coronary artery bypass graft surgery--a comparison of three different deep breathing techniques. J Rehabil Med. 2001 Mar;33(2):79-84. doi: 10.1080/165019701750098920.
PubMed 11474953
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blow-bottle Technique and Interdigital Breathing for Pulmonary Function of Post-laparotomy Patients .
- ClinicalTrials.gov ID
- NCT04913428
- Acronym / sponsor ID
- REC/00313 Huda Anjum
- Conditions
- Laparotomy Patients
- Keywords
- Pulmonary function, Chest expansion, Laparotomy, Spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 4 Jun 2021 (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.
The study is designed to compare the effects of blow bottle technique and interdigital exercises on the pulmonary functions of the post laparotomy patients where there is sudden decline in lung function and increased rate of complications after the surgery. A randomized control trial was conducted including post laparotomy patients, randomly allocated to interventional and control groups. Both the groups received breathing exercises along with conventional treatment during phase I rehabilitation. Data was collected at baseline, before and after every session and after 6 sessions before patient discharge from hospital. Outcome measures include assessment of lung volumes and capacities, oxygen saturation and vitals of the post laparotomy patients
Detailed description
Pulmonary complications are common in post laparotomy patients because of multiple pre operative, intra operative and post operative factors. To manage these complications many interventions and breathing techniques are used. These complications alter the pulmonary function leading to decreased chest expansion, oxygen saturation and post operative atelectasis. Anesthetic drugs that also cause cardiac depression along with hemodynamic instability of the patient. Incision given to the chest or abdominal wall during procedure causes to lose the integrity of respiratory muscles which effects the functions of the muscle directly. Respiratory muscles are compromised, normal lung volumes are depressed. More than 75% of patients who are receiving neuromuscular blocking agent develops atelectasis. The estimated time after surgery for patient to return to its preoperative health status is approximately 6 weeks. These complications increase the hospital length of stay and cost associated with it as well as increase the morbidity and mortality.
Lung expansion techniques (LETs) are widely used to prevent postoperative pulmonary complications (PPCs). However, the effects of each of these techniques on thoraco-abdominal mechanics and PPC incidence after abdominal surgery remain unclear. Active Cycle of Breathing Techniques (ACBT) has shown to be effective in mobilizing and clearing the excess bronchial secretions and to improve lung function. It neither causes nor increases hypoxemia or increases airflow obstruction. Chest physiotherapy and breathing exercises are often prescribed to patients undergoing cardiac surgery and abdominal surgery in order to prevent or reduce post-operative pulmonary complications. There are different breathing techniques with and without mechanical devices after the surgery, but there is controversy regarding which breathing techniques are the most effective.
Researches have proved change in pulmonary functions by the use of various breathing exercises. Depressed pulmonary functions i.e. decreased forced vital capacity (FVC) , decreased forced expiratory volume (FEV1), Peak Expiratory Flow Rate (PEFR) are seen as result of disturbed lung function. Alteration in function of diaphragm contributes in postoperatively pulmonary function disturbances. Chest physiotherapy is implied for minimizing the altered lung functions and complications. This includes multiple breathing exercises, percussion , vibrations, huffing, coughing techniques, postural drainage and mobilization.
The current study is conducted to compare two respiratory techniques for the improvement in post operative pulmonary function; because of incisional pain, patients find the inspiratory exercises difficult to perform, therefore, the study is conducted to assess if easy-to -perform expiratory techniques are similar in effect to the inspiratory techniques and for the said purpose comparison of blow bottle technique and interdigital breathing on post laparotomy patients is made for the improvement of pulmonary function and vitals of these patients.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdigital exercise group | Experimental | Other: Interdigital exerciseInterdigital exercises: 12 repetitions in 3 sets of 4 repetitions Conventional Physical Therapy: Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes |
| Blow-Bottle technique group | Active comparator | Other: Blow-Bottle techniqueBlow-Bottle technique: 12 repetitions in 3 sets of 4 repetitions Conventional Physical Therapy: Incentive spirometer 3 - 4 times a day, Percussion twice a day, Mobilization of the patient Total session given was for 20 -30 minutes |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post laparotomy patients
- Age 25 to 45 years.
- Both genders.
Key exclusion criteria (3 listed)
- Vitally unstable patients
- Complicated laparotomies
- Patients with post-operative complications e.g. delirium
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 |
|---|---|---|
| Interdigital exercisePatient asked to sit in upright position interlocking their fingers with inhaling deeply bringing the arms up and exhaling through mouth while bring the arm down. | Other | Interdigital exercise group |
| Blow-Bottle techniqueFor blow bottle 20cm of bottle filled with 10cm of water in which a tube of length 35- 40cm inserted with the inner diameter of ≥8mm(21).Patient is asked to form bubbles in bottle by exhaling in bottle performing Forced Expiratory Techniques. | Other | Blow-Bottle technique group |
Primary outcome
Peak expiratory flow rate (PEFR)
Time frame: 5 days
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Forced vital capacity (FVC)
Time frame: 5 days
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Forced expiratory volume in 1sec (FEV1)
Time frame: 5 days
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.
FVC/FEV1
Time frame: 5 days
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
4 secondary outcomes
Oxygen Saturation (SPO2)
Time frame: 5 days
Heart rate
Time frame: 5 days
Chest expansion
Time frame: 5 days
Respiratory rate
Time frame: 5 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 4 Jun 2021.
- Background: PubMed 11978282Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon B, Laffargue F. Pfannenstiel versus Maylard incision for cesarean delivery: A randomized controlled trial. Obstet Gynecol. 2002 May;99(5 Pt 1):745-50. doi: 10.1016/s0029-7844(02)01957-9.
- Background: PubMed 28186222Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Background: PubMed 25125786Dagan Y, Wiser I, Weissman O, Farber N, Hundeshagen G, Winkler E, Kazula-Halabi T, Haik J. An Improvised "Blow Glove" Device Produces Similar PEP Values to a Commercial PEP Device: An Experimental Study. Physiother Can. 2014 Summer;66(3):308-12. doi: 10.3138/ptc.2013-31.
- Background: PubMed 27525116Alaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.
- Background: PubMed 7006464Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
- Background: PubMed 23429831Agostini P, Naidu B, Cieslik H, Steyn R, Rajesh PB, Bishay E, Kalkat MS, Singh S. Effectiveness of incentive spirometry in patients following thoracotomy and lung resection including those at high risk for developing pulmonary complications. Thorax. 2013 Jun;68(6):580-5. doi: 10.1136/thoraxjnl-2012-202785. Epub 2013 Feb 21.
- Background: PubMed 25607594Tyson AF, Kendig CE, Mabedi C, Cairns BA, Charles AG. The effect of incentive spirometry on postoperative pulmonary function following laparotomy: a randomized clinical trial. JAMA Surg. 2015 Mar 1;150(3):229-36. doi: 10.1001/jamasurg.2014.1846.
- Background: PubMed 25973670Lunardi AC, Paisani DM, Silva CCBMD, Cano DP, Tanaka C, Carvalho CRF. Comparison of lung expansion techniques on thoracoabdominal mechanics and incidence of pulmonary complications after upper abdominal surgery: a randomized and controlled trial. Chest. 2015 Oct;148(4):1003-1010. doi: 10.1378/chest.14-2696.
- Background: PubMed 11474953Westerdahl E, Lindmark B, Almgren SO, Tenling A. Chest physiotherapy after coronary artery bypass graft surgery--a comparison of three different deep breathing techniques. J Rehabil Med. 2001 Mar;33(2):79-84. doi: 10.1080/165019701750098920.
- Individual participant dataSharing planned: No
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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.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdigital exercise and Blow-Bottle technique in people with Laparotomy Patients, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 3 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 4 Jun 2021. 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 Pakistan. 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?
Peak expiratory flow rate (PEFR) (time frame: 5 days). The study lists 4 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 NCT04913428, which also lists 9 linked publications.
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 4 Jun 2021.