Incentive SpirometryNCT05795608
Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery
A study testing respiratory exercise with incentive spirometry in people with Incentive Spirometry and Postoperative Pulmonary Complication, run by Dr Cipto Mangunkusumo General Hospital.
Trial summary
This study is the first clinical trial study in Indonesia to assess the benefits of using incentive spirometry in the incidence of pulmonary complications after major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Incentive Spirometry, Postoperative Pulmonary Complication, Major Abdominal Surgery
- What is being tested?
- respiratory exercise with incentive spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 Sep 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing major abdominal surgery
- aged between 18 and 65 years old
- Sign research informed consent
Who cannot join
- Emergency surgery
- Have a history of lung disorders
- Refusing to continue incentive spirometry
- Patients who cannot follow instructions in using the device incentive spirometry.
About this study
Official title: Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery In Indonesia Three Major Tertiary Hospitals: A Randomized Controlled Trial
This study is the first clinical trial study in Indonesia to assess the benefits of using incentive spirometry in the incidence of pulmonary complications after major abdominal surgery.
This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The investigators randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups.
Read more
All study subjects were simple randomly allocated to the intervention and control groups according to the randomization table.
The hypothesis of the study team was that preoperative incentive spirometry can improve the incidence of postoperative pulmonary complications in major abdominal surgery
Read the detailed description
This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The researchers randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups.
The researchers included patients aged between 18 and 65 years old who underwent elective major abdominal surgery into random allocation. Patients were excluded if had a history of pulmonary disease and were unwilling or unable to take a deep breath effectively due to pain, diaphragmatic dysfunction, or opiate analgesia.
All study subjects were simple randomly allocated into the intervention and control groups according to the randomization table. The intervention group (23 subjects) received respiratory exercise with incentive spirometry before surgery, and the control group (23 subjects) were given standard preoperative care.
Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, The subjects were asked to inhale deeply and slowly, and were also directed to hold their breath at the end of inspiration.
With alpha of 5%, beta of 10%, 39% postoperative pulmonary complication rate, as mentioned in the previous study,13 and assumption of that incentive spirometry can reduce the PPC to 30%, this study required at least 23 subjects in each group to see the effectiveness of using incentive spirometry before surgery in preventing PPC.
Measures In the intervention group, pulmonary function (vital capacity [VC], vital functional capacity [VFC], and Forced expiratory volume in the first second [FEV1]) were measured three times: two times before surgery (first day before undergoing the incentive spirometry procedure and second day after using the incentive spirometry) and one time after surgery. The control group measured pulmonary function three times: two times before surgery (on the first day of admission, on the day before surgery) and one time after surgery. In addition, postoperative pulmonary function was measured up to seven days following abdominal surgery, depending on the patient's ability.
On the first day after surgery, all subjects were examined by a pulmonologist, supplemented with a chest x-ray and blood gas analysis to assess the occurrence of postoperative pulmonary complications. PPC in this study included atelectasis (lung volume diminishing, caused by inadequate expansion of air cavity within lung parenchyma), pneumonia (all kinds of lung infection), and hypoxemia (ratio of PaO2: FiO2 less than 300).
The researchers used means (standard deviation, SD) and numbers (percentage,%) to describe the baseline subjects demographic and clinical characteristics. Henceforth, The researchers compared the change in lung function before and after surgery between intervention and control groups. An unpaired T-test was conducted to determine if the data were normally distributed. Alternatively, the Mann-Whitney test was done for abnormally distributed data. The researchers analyzed the comparison of lung complication incidence between experimental and control groups using chi-square or Fisher's exact test method. In this study, The researchers investigated the lung function of the experimental group before and after the incentive spirometry procedure.
- Being tested
- respiratory exercise with incentive spirometry
- Keywords
- Incentive spirometry, major abdominal surgery, pulmonary complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory exercise with incentive spirometryDevice
Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The intervention group received respiratory exercise with incentive spirometry before surgery Receives: Device: respiratory exercise with incentive spirometry |
| control group | No intervention | The control group were given standard preoperative care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with atelectasis
The loss of lung volume is caused by inadequate expansion of the air spaces lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist
Measured: day 1 until day 7
number of participants with pneumonia
Any form of infection of the lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist
Measured: day 1 until day 7
number of participants with hypoxaemia
Hypoxaemia was defined as PaO2/FiO2 <300 as assessed by blood gas analysis
Measured: day 1 until day 7
Secondary outcomes (3)
vital capacity
It is the total amount of air exhaled after maximal inhalation
Measured: Preoperative, day 1 before surgery, and until day 7 after surgery
forced vital capacity
the maximum amount of air you can forcibly exhale from your lungs after fully inhaling
Measured: Preoperative, day 1 before surgery, and until day 7 after surgery
Forced expiratory volume in the first second
the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
Measured: Preoperative, day 1 before surgery, and until day 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Jul 2015
- Primary completion10 Aug 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Incentive SpirometryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ridho Ardhi Syaiful, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795608
- Sponsor's protocol ID
- RSyaiful
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data in this study cannot be shared because the research database is no longer available due to damage to the hard disk where the data is stored.
Publications
McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.
PubMed 15563632Hall JC, Tarala RA, Hall JL, Mander J. A multivariate analysis of the risk of pulmonary complications after laparotomy. Chest. 1991 Apr;99(4):923-7. doi: 10.1378/chest.99.4.923.
PubMed 2009796Kodra N, Shpata V, Ohri I. Risk Factors for Postoperative Pulmonary Complications after Abdominal Surgery. Open Access Maced J Med Sci. 2016 Jun 15;4(2):259-63. doi: 10.3889/oamjms.2016.059. Epub 2016 May 22.
PubMed 27335597Kehrer HE. [Infantile autism and drug therapy]. Bibl Psychiatr. 1978;(157):91-7. No abstract available. German.
PubMed 348194Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
PubMed 24155356Haines KJ, Skinner EH, Berney S; Austin Health POST Study Investigators. Association of postoperative pulmonary complications with delayed mobilisation following major abdominal surgery: an observational cohort study. Physiotherapy. 2013 Jun;99(2):119-25. doi: 10.1016/j.physio.2012.05.013. Epub 2012 Sep 23.
PubMed 23219632Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
PubMed 12682500Lyager S, Wernberg M, Rajani N, Boggild-Madsen B, Nielsen L, Nielsen HC, Andersen M, Moller J, Silberschmid M. Can postoperative pulmonary conditions be improved by treatment with the Bartlett-Edwards incentive spirometer after upper abdominal surgery? Acta Anaesthesiol Scand. 1979 Aug;23(4):312-9. doi: 10.1111/j.1399-6576.1979.tb01456.x.
PubMed 495034Patel K, Hadian F, Ali A, Broadley G, Evans K, Horder C, Johnstone M, Langlands F, Matthews J, Narayan P, Rallon P, Roberts C, Shah S, Vohra R. Postoperative pulmonary complications following major elective abdominal surgery: a cohort study. Perioper Med (Lond). 2016 May 23;5:10. doi: 10.1186/s13741-016-0037-0. eCollection 2016.
PubMed 27222707Yang CK, Teng A, Lee DY, Rose K. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res. 2015 Oct;198(2):441-9. doi: 10.1016/j.jss.2015.03.028. Epub 2015 Mar 18.
PubMed 25930169Kim TH, Lee JS, Lee SW, Oh YM. Pulmonary complications after abdominal surgery in patients with mild-to-moderate chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2016 Nov 9;11:2785-2796. doi: 10.2147/COPD.S119372. eCollection 2016.
PubMed 27877032Avila AC, Fenili R. Incidence and risk factors for postoperative pulmonary complications in patients undergoing thoracic and abdominal surgeries. Rev Col Bras Cir. 2017 May-Jun;44(3):284-292. doi: 10.1590/0100-69912017003011. English, Portuguese.
PubMed 28767805Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major surgeries: a systematic review. Rev Bras Fisioter. 2011 Sep-Oct;15(5):343-50. doi: 10.1590/s1413-35552011005000025. Epub 2011 Oct 14.
PubMed 22002191Thomas JA, McIntosh JM. Are incentive spirometry, intermittent positive pressure breathing, and deep breathing exercises effective in the prevention of postoperative pulmonary complications after upper abdominal surgery? A systematic overview and meta-analysis. Phys Ther. 1994 Jan;74(1):3-10; discussion 10-6. doi: 10.1093/ptj/74.1.3.
PubMed 8265725Tyson 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 25607594
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Incentive Spirometry on Postoperative Pulmonary Complication After Major Abdominal Surgery In Indonesia Three Major Tertiary Hospitals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05795608
- Acronym / sponsor ID
- RSyaiful
- Keywords
- Incentive spirometry, major abdominal surgery, pulmonary complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 10 Aug 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 3 Apr 2023 (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.
This study is the first clinical trial study in Indonesia to assess the benefits of using incentive spirometry in the incidence of pulmonary complications after major abdominal surgery.
This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The investigators randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups.
All study subjects were simple randomly allocated to the intervention and control groups according to the randomization table.
The hypothesis of the study team was that preoperative incentive spirometry can improve the incidence of postoperative pulmonary complications in major abdominal surgery
Detailed description
This study was a randomized clinical trial in three tertiary-level referral hospitals in Indonesia (Cipto Mangunkusumo Hospital, Fatmawati Hospital, and Persahabatan Hospital). The researchers randomly assigned adult patients who underwent major abdominal elective surgery in July-August 2015 to two groups.
The researchers included patients aged between 18 and 65 years old who underwent elective major abdominal surgery into random allocation. Patients were excluded if had a history of pulmonary disease and were unwilling or unable to take a deep breath effectively due to pain, diaphragmatic dysfunction, or opiate analgesia.
All study subjects were simple randomly allocated into the intervention and control groups according to the randomization table. The intervention group (23 subjects) received respiratory exercise with incentive spirometry before surgery, and the control group (23 subjects) were given standard preoperative care.
Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, The subjects were asked to inhale deeply and slowly, and were also directed to hold their breath at the end of inspiration.
With alpha of 5%, beta of 10%, 39% postoperative pulmonary complication rate, as mentioned in the previous study,13 and assumption of that incentive spirometry can reduce the PPC to 30%, this study required at least 23 subjects in each group to see the effectiveness of using incentive spirometry before surgery in preventing PPC.
Measures In the intervention group, pulmonary function (vital capacity [VC], vital functional capacity [VFC], and Forced expiratory volume in the first second [FEV1]) were measured three times: two times before surgery (first day before undergoing the incentive spirometry procedure and second day after using the incentive spirometry) and one time after surgery. The control group measured pulmonary function three times: two times before surgery (on the first day of admission, on the day before surgery) and one time after surgery. In addition, postoperative pulmonary function was measured up to seven days following abdominal surgery, depending on the patient's ability.
On the first day after surgery, all subjects were examined by a pulmonologist, supplemented with a chest x-ray and blood gas analysis to assess the occurrence of postoperative pulmonary complications. PPC in this study included atelectasis (lung volume diminishing, caused by inadequate expansion of air cavity within lung parenchyma), pneumonia (all kinds of lung infection), and hypoxemia (ratio of PaO2: FiO2 less than 300).
The researchers used means (standard deviation, SD) and numbers (percentage,%) to describe the baseline subjects demographic and clinical characteristics. Henceforth, The researchers compared the change in lung function before and after surgery between intervention and control groups. An unpaired T-test was conducted to determine if the data were normally distributed. Alternatively, the Mann-Whitney test was done for abnormally distributed data. The researchers analyzed the comparison of lung complication incidence between experimental and control groups using chi-square or Fisher's exact test method. In this study, The researchers investigated the lung function of the experimental group before and after the incentive spirometry procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: respiratory exercise with incentive spirometryThe intervention group received respiratory exercise with incentive spirometry before surgery |
| control group | No intervention | –The control group were given standard preoperative care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing major abdominal surgery
- aged between 18 and 65 years old
- Sign research informed consent
Key exclusion criteria (4 listed)
- Emergency surgery
- Have a history of lung disorders
- Refusing to continue incentive spirometry
- Patients who cannot follow instructions in using the device incentive spirometry.
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 |
|---|---|---|
| respiratory exercise with incentive spirometrySubjects in the intervention group were trained to perform 15 minutes of respiratory exercise with incentive spirometry four times a day for two days before surgery by trained medical personnel. First, subjects were instructed to make a good seal over the incentive spirometry mouthpiece with their lips. Afterward, they were asked to inhale deeply and slowly, and they were also directed to hold their breath at the end of inspiration | Device | intervention group |
Primary outcome
number of participants with atelectasis
Time frame: day 1 until day 7
The loss of lung volume is caused by inadequate expansion of the air spaces lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist
number of participants with pneumonia
Time frame: day 1 until day 7
Any form of infection of the lung parenchyma. Assess based on plain chest X-rays examined by radiology and clinical assessment of a pulmonologist
number of participants with hypoxaemia
Time frame: day 1 until day 7
Hypoxaemia was defined as PaO2/FiO2 <300 as assessed by blood gas analysis
3 secondary outcomes
vital capacity
Time frame: Preoperative, day 1 before surgery, and until day 7 after surgery
forced vital capacity
Time frame: Preoperative, day 1 before surgery, and until day 7 after surgery
Forced expiratory volume in the first second
Time frame: Preoperative, day 1 before surgery, and until day 7 after surgery
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 5 Apr 2023.
- Background: PubMed 15563632McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.
- Background: PubMed 2009796Hall JC, Tarala RA, Hall JL, Mander J. A multivariate analysis of the risk of pulmonary complications after laparotomy. Chest. 1991 Apr;99(4):923-7. doi: 10.1378/chest.99.4.923.
- Background: PubMed 27335597Kodra N, Shpata V, Ohri I. Risk Factors for Postoperative Pulmonary Complications after Abdominal Surgery. Open Access Maced J Med Sci. 2016 Jun 15;4(2):259-63. doi: 10.3889/oamjms.2016.059. Epub 2016 May 22.
- Background: PubMed 348194Kehrer HE. [Infantile autism and drug therapy]. Bibl Psychiatr. 1978;(157):91-7. No abstract available. German.
- Background: PubMed 24155356Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
- Background: PubMed 23219632Haines KJ, Skinner EH, Berney S; Austin Health POST Study Investigators. Association of postoperative pulmonary complications with delayed mobilisation following major abdominal surgery: an observational cohort study. Physiotherapy. 2013 Jun;99(2):119-25. doi: 10.1016/j.physio.2012.05.013. Epub 2012 Sep 23.
- Background: PubMed 12682500Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
- Background: PubMed 495034Lyager S, Wernberg M, Rajani N, Boggild-Madsen B, Nielsen L, Nielsen HC, Andersen M, Moller J, Silberschmid M. Can postoperative pulmonary conditions be improved by treatment with the Bartlett-Edwards incentive spirometer after upper abdominal surgery? Acta Anaesthesiol Scand. 1979 Aug;23(4):312-9. doi: 10.1111/j.1399-6576.1979.tb01456.x.
- Results publication: PubMed 27222707Patel K, Hadian F, Ali A, Broadley G, Evans K, Horder C, Johnstone M, Langlands F, Matthews J, Narayan P, Rallon P, Roberts C, Shah S, Vohra R. Postoperative pulmonary complications following major elective abdominal surgery: a cohort study. Perioper Med (Lond). 2016 May 23;5:10. doi: 10.1186/s13741-016-0037-0. eCollection 2016.
- Results publication: PubMed 25930169Yang CK, Teng A, Lee DY, Rose K. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res. 2015 Oct;198(2):441-9. doi: 10.1016/j.jss.2015.03.028. Epub 2015 Mar 18.
- Results publication: PubMed 27877032Kim TH, Lee JS, Lee SW, Oh YM. Pulmonary complications after abdominal surgery in patients with mild-to-moderate chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2016 Nov 9;11:2785-2796. doi: 10.2147/COPD.S119372. eCollection 2016.
- Results publication: PubMed 28767805Avila AC, Fenili R. Incidence and risk factors for postoperative pulmonary complications in patients undergoing thoracic and abdominal surgeries. Rev Col Bras Cir. 2017 May-Jun;44(3):284-292. doi: 10.1590/0100-69912017003011. English, Portuguese.
- Individual participant dataSharing planned: No. The data in this study cannot be shared because the research database is no longer available due to damage to the hard disk where the data is stored.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory exercise with incentive spirometry in people with Incentive Spirometry and Postoperative Pulmonary Complication, run by Dr Cipto Mangunkusumo General Hospital.
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 4 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
number of participants with atelectasis (time frame: day 1 until day 7). The study lists 3 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 NCT05795608, which also lists 21 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 5 Apr 2023.