CholelithiasisNCT06115941
Using Pre-op Incentive Spirometer Reduces Chances of Basal Atelectasis in Patients Undergoing Upper Abdominal Surgeries
A study testing Pre-Op Incentive Spirometer in people with Cholelithiasis and Epigastric Hernia, run by Dr. Muhammad Naeem at 1 site in Pakistan.
Trial summary
ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry Read more about this study
- Who is it for?
- Ages 18 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis, Epigastric Hernia, Duodenal Perforation
- What is being tested?
- Pre-Op Incentive Spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Mar 2023to 28 Sep 2023
- 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 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age above 18 years
- Both gender
- ASA I and II
- Upper abdominal surgeries
Who cannot join
- Lower abdominal surgeries,
- ASA III-V status,
- Co-morbidities [like diabetes (HbA1C% ≥ 6.5% 11), hypertension
- Smoking
- Chronic lung condition (like asthma, chronic obstructive pulmonary disease, emphysema)
- Pulmonary tuberculosis
- Structural deformity of chest.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Using Pre-Operative Incentive Spirometer Reduces Chances of Basal Ateletasis in Patients Undergoing Upper Abdominal Surgeries- A Randomized Control Trial
ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry
Read the detailed description
After patient selection through "non-probability consecutive sampling" Investigator recorded baseline characteristics of our patients including age, gender and body mass index (BMI). Once recorded, patients will be randomly divided into two equal groups (each containing 37 patients). In group A or "incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.
After this, all the included patients underwent upper abdominal surgery by expert surgical team under general anesthesia. Type of surgery (Laparoscopic Cholecystectomy / Open Cholecystectomy / perforated duodenal repair/ Epigastric Hernia Repair / Gastrojejunostomy) and duration for which patient was on ventilator support (in minutes) was documented. After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung".
"The statistical package for social sciences (SPSS) version 22 software was used for statistical analysis of the data. Normality of test will be checked using Shapiro-Wilk test which showed that age and BMI were normally distributed while duration of ventilatory support was non-normal data. For qualitative variables frequency and percentages were used, whereas for quantitative data mean ± standard deviation and median (IQR) were used. Qualitative variables (gender, type of surgery and presence of basal atelectasis) were compared between groups with the use of chi-square test. Quantitative variable (age and BMI) were compared between groups using Student t-test while (duration of ventilatory support) were compared between groups using Mann-Whittney U-test. A p-value of ≤ 0.05 was considered significant".
- Conditions
- Cholelithiasis, Epigastric Hernia, Duodenal Perforation
- Being tested
- Pre-Op Incentive Spirometer
- Keywords
- Abdominal Surgery, Atelectasis, Incentive spirometry
- Medical subject headings
- Cholelithiasis, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Op Incentive SpirometerDevice
incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file.
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometer group | Experimental | incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. Receives: Device: Pre-Op Incentive Spirometer |
| No Incentive spirometer group | No intervention | In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased frequency in post operative Basal Atelectasis
After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung
Measured: 48 hours 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 Nov 2023
- Study start29 Mar 2023
- Primary completion28 Aug 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Muhammad Naeem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Muhammad Naeem, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115941
- Sponsor's protocol ID
- 265
- Status last verified
- Nov 2023
- First submitted
- 24 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Pre-Operative Incentive Spirometer Reduces Chances of Basal Ateletasis in Patients Undergoing Upper Abdominal Surgeries- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06115941
- Acronym / sponsor ID
- 265
- Conditions
- Cholelithiasis, Epigastric Hernia, Duodenal Perforation
- Keywords
- Abdominal Surgery, Atelectasis, Incentive spirometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Dr. Muhammad NaeemUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 3 Nov 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.
ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry
Detailed description
After patient selection through "non-probability consecutive sampling" Investigator recorded baseline characteristics of our patients including age, gender and body mass index (BMI). Once recorded, patients will be randomly divided into two equal groups (each containing 37 patients). In group A or "incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.
After this, all the included patients underwent upper abdominal surgery by expert surgical team under general anesthesia. Type of surgery (Laparoscopic Cholecystectomy / Open Cholecystectomy / perforated duodenal repair/ Epigastric Hernia Repair / Gastrojejunostomy) and duration for which patient was on ventilator support (in minutes) was documented. After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung".
"The statistical package for social sciences (SPSS) version 22 software was used for statistical analysis of the data. Normality of test will be checked using Shapiro-Wilk test which showed that age and BMI were normally distributed while duration of ventilatory support was non-normal data. For qualitative variables frequency and percentages were used, whereas for quantitative data mean ± standard deviation and median (IQR) were used. Qualitative variables (gender, type of surgery and presence of basal atelectasis) were compared between groups with the use of chi-square test. Quantitative variable (age and BMI) were compared between groups using Student t-test while (duration of ventilatory support) were compared between groups using Mann-Whittney U-test. A p-value of ≤ 0.05 was considered significant".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometer group | Experimental | Device: Pre-Op Incentive Spirometerincentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. |
| No Incentive spirometer group | No intervention | –In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry. |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age above 18 years
- Both gender
- ASA I and II
- Upper abdominal surgeries
Key exclusion criteria (7 listed)
- Lower abdominal surgeries,
- ASA III-V status,
- Co-morbidities [like diabetes (HbA1C% ≥ 6.5% 11), hypertension
- Smoking
- Chronic lung condition (like asthma, chronic obstructive pulmonary disease, emphysema)
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 |
|---|---|---|
| Pre-Op Incentive Spirometerincentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. | Device | Incentive spirometer group |
Primary outcome
Decreased frequency in post operative Basal Atelectasis
Time frame: 48 hours after surgery
After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung
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 3 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Op Incentive Spirometer in people with Cholelithiasis and Epigastric Hernia, run by Dr. Muhammad Naeem 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 4 inclusion and 7 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 3 Nov 2023. 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?
Decreased frequency in post operative Basal Atelectasis (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2023.