Surgical Procedure, UnspecifiedNCT01993602
Lung Expansion Technics on Chest Wall Mechanics and Preventing Pulmonary Complication After Abdominal Surgery
A study testing Breathing exercises in people with Surgical Procedure, Unspecified, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Breathing exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Oct 2013
- 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
- candidates for elective upper abdominal surgery expected to last longer than 120 minutes
- absent of spine or thoracic deformity
- no previous lung parenchyma resection
- no tracheostomy
- able to understand and perform the maneuvers proposed.
Who cannot join
- cancellation of surgery
- mechanical ventilation for more than 24 hours in the postoperative period
- need for chest tube use
- postoperative cardiac complications
- surgical complication
- reoperation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital of Clinics of School of Medicine of University of Sao Paulo
São Paulo, São Paulo, 05403-010
About this study
Official title: COMPARISON OF LUNG EXPANSION TECHNICS ON THORACOABDOMINAL MECHANICS AND THEIR INFLUENCE ON THE INCIDENCE OF PULMONARY COMPLICATIONS AFTER ABDOMINAL SURGERY: A RANDOMIZED AND CONTROLLED CLINICAL TRIAL
The lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. The investigators hypothesis is that the lung expansion technique that more increases lung volume after abdominal surgery, will be the most efficient in preventing postoperative pulmonary complication after abdominal surgery. The investigators objectives will be to compare the effect of different lung expansion techniques on lung volumes and activation of inspiratory muscle, and prevention of pulmonary complications in patients undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35), continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS, n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications will be evaluated by a researcher who did not know to which group each patient belongs.
Read the detailed description
The assessments performed were thoracoabdominal kinematics (by optoelectronic pletysmography)and respiratory muscles activity (by surface electromyography). The follow pulmonary complications were considered: pneumonia, tracheobronchitis, atelectasis and acute respiratory failed
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Breathing exercises
- Keywords
- general surgery, postoperative care, breathing exercises, respiratory muscle, postoperative complications, lung volume measurements, pulmonary ventilations, thoracic wall
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesProcedure or surgery
The intervention groups (CPAP, VIS, FIS and DB) used the specific device (or not) according to the group allocation.
The intervention was performed 3 times per day, from 1 to 5 postoperative day. Patients performed 5 sets of 10 repetitions of the specific breathing exercise, with 30 seconds rest between each set.
The sessions were held in the morning, early afternoon and early evening, always supervised by a physiotherapist.
Before starting each session, the patient reported the sensation of pain, and if he quantify pain intensity more than 3 in the visual numeric scale (0 to 10) was asked the doctor to administer analgesics aiming that him to perform properly the breathing exercise.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | no intervention was performed in this group during postoperative period, |
| volumetric incentive spirometry | Active comparator | patients performed breathing exercises using volumetric incentive spirometer during five postoperative days Receives: Procedure: Breathing exercises |
| Flow oriented incentive spirometry | Active comparator | patients performed breathing exercises using flow oriented incentive spirometer during five postoperative days Receives: Procedure: Breathing exercises |
| Deep breathing group | Active comparator | patients performed deep breathing exercises without any device during five postoperative days Receives: Procedure: Breathing exercises |
| Continuous positive airway pressure group | Active comparator | patients performed breathing exercises using continuous positive airway pressure group during five postoperative days Receives: Procedure: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
thoracoabdominal volume
thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)
Measured: third postoperative day
Secondary outcomes (1)
postoperative pulmonary complication
evaluation of pulmonary complications was performed according to pre-established criteria in the research project
Measured: participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionOct 2013
- Study completionOct 2013
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 Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Celso R Carvalho, PhD, Principal investigator, School of Medicine of University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993602
- Sponsor's protocol ID
- 0150/11
- Other IDs
- FAPESP
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lunardi 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 25973670
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF LUNG EXPANSION TECHNICS ON THORACOABDOMINAL MECHANICS AND THEIR INFLUENCE ON THE INCIDENCE OF PULMONARY COMPLICATIONS AFTER ABDOMINAL SURGERY: A RANDOMIZED AND CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT01993602
- Acronym / sponsor ID
- 0150/11
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- general surgery, postoperative care, breathing exercises, respiratory muscle, postoperative complications, lung volume measurements, pulmonary ventilations, thoracic wall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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 lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. The investigators hypothesis is that the lung expansion technique that more increases lung volume after abdominal surgery, will be the most efficient in preventing postoperative pulmonary complication after abdominal surgery. The investigators objectives will be to compare the effect of different lung expansion techniques on lung volumes and activation of inspiratory muscle, and prevention of pulmonary complications in patients undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35), continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS, n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications will be evaluated by a researcher who did not know to which group each patient belongs.
Detailed description
The assessments performed were thoracoabdominal kinematics (by optoelectronic pletysmography)and respiratory muscles activity (by surface electromyography). The follow pulmonary complications were considered: pneumonia, tracheobronchitis, atelectasis and acute respiratory failed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –no intervention was performed in this group during postoperative period, |
| volumetric incentive spirometry | Active comparator | Procedure: Breathing exercisespatients performed breathing exercises using volumetric incentive spirometer during five postoperative days |
| Flow oriented incentive spirometry | Active comparator | Procedure: Breathing exercisespatients performed breathing exercises using flow oriented incentive spirometer during five postoperative days |
| Deep breathing group | Active comparator | Procedure: Breathing exercisespatients performed deep breathing exercises without any device during five postoperative days |
| Continuous positive airway pressure group | Active comparator | Procedure: Breathing exercisespatients performed breathing exercises using continuous positive airway pressure group during five postoperative days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- candidates for elective upper abdominal surgery expected to last longer than 120 minutes
- absent of spine or thoracic deformity
- no previous lung parenchyma resection
- no tracheostomy
- able to understand and perform the maneuvers proposed.
Key exclusion criteria (6 listed)
- cancellation of surgery
- mechanical ventilation for more than 24 hours in the postoperative period
- need for chest tube use
- postoperative cardiac complications
- surgical complication
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 |
|---|---|---|
| Breathing exercisesThe intervention groups (CPAP, VIS, FIS and DB) used the specific device (or not) according to the group allocation. The intervention was performed 3 times per day, from 1 to 5 postoperative day. Patients performed 5 sets of 10 repetitions of the specific breathing exercise, with 30 seconds rest between each set. The sessions were held in the morning, early afternoon and early evening, always supervised by a physiotherapist. Before starting each session, the patient reported the sensation of pain, and if he quantify pain intensity more than 3 in the visual numeric scale (0 to 10) was asked the doctor to administer analgesics aiming that him to perform properly the breathing exercise. | Procedure or surgery | Continuous positive airway pressure group, Deep breathing group, Flow oriented incentive spirometry, volumetric incentive spirometry |
Primary outcome
thoracoabdominal volume
Time frame: third postoperative day
thoracoabdominal volume was evaluated by kinematics (optoelectronic plethysmograph)
1 secondary outcome
postoperative pulmonary complication
Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 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 8 Mar 2016.
- Derived from this study: 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.
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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.
Celso R Carvalho, PhD principal investigator
School of Medicine of University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Surgical Procedure, Unspecified, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 5 inclusion and 6 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 8 Mar 2016. 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 Brazil. 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?
thoracoabdominal volume (time frame: third postoperative day). 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 NCT01993602, 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 8 Mar 2016.