Atelectases, Postoperative PulmonaryEarly Phase 1NCT07591558
The Role Intraoperative Salbutamol Inhaler in Preventing Atelectasis
A Early Phase 1 study testing Salbutamol (Ventolin®) in people with Atelectases, Postoperative Pulmonary and Diabete Mellitus, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atelectases, Postoperative Pulmonary, Diabete Mellitus
- What is being tested?
- Salbutamol (Ventolin®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- Jun 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will include patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status of I or II
- Will undergo thoracic, abdominal or spinal surgery
Who cannot join
- cardiac conditions other than hypertension like arrhythmia
- previous cardiac surgeries and valvular heart diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
King Abdullah University Hospital
Irbid
Principal Investigator Principal Investigator
About this study
Official title: The Role Intraoperative Salbutamol Inhaler Usage as Part of Intraoperative Regimen in Preventing Atelectasis Following Thoracic, Abdominal and Spinal Surgery in Diabetics Population
Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications, including hypoxemia and pneumonia. In the literature, several methods were utilized to combat this phenomenon, therefore, we investigate the role of intraoperative salbutamol in reducing the incidence of atelectasis. It is well known that salbutamol could be an adjunctive bronchodilator medication used in the intraoperative anesthetic regimens.
Read the detailed description
Atelectasis is the collapse or incomplete expansion of the lung or a part of it, resulting in impaired gas exchange and potential hypoxemia. It is a common complication in various clinical settings, particularly after surgery, and can contribute to increased morbidity and prolonged hospital stay. The incidence of atelectasis varies widely depending on the patient population and type of surgical procedure. Postoperative atelectasis is reported in up to 90% of patients undergoing general anesthesia, with higher rates observed in thoracic and upper abdominal surgeries. In pediatric populations, the incidence may range from 10-25%, especially following gastrointestinal or thoracic procedures. Key risk factors include general anesthesia, postoperative pain, obesity, advanced age, smoking, prolonged immobility, neuromuscular disorders, and mechanical ventilation. These factors contribute to reduced diaphragmatic motion, impaired mucociliary clearance, and decreased alveolar ventilation. There are several causes of atelectasis in the postoperative period which results from a combination of factors that impair normal lung expansion and ventilation as reduced functional residual capacity as general anesthesia decreases FRC below closing volume, especially in dependent lung areas, promoting alveolar collapse. Impaired diaphragmatic function as pain and muscle relaxation reduce diaphragmatic motion, limiting lung inflation post-surgery. In addition, mucus retention due to suppressed cough reflex and ciliary function leads to resorptive (obstructive) atelectasis. Another important mechanism for atelectasis is airway obstruction and reflex bronchospasm. Management of atelectasis depends mainly on prevention and lung re-expansion strategies and it is divided according to period. In the preoperative period, smoking cessation at least 4-8 weeks before surgery reduces risk and patient education on deep breathing and coughing exercises. In the intraoperative period, the use of lung-protective ventilation as low tidal volumes with adequate PEEP (positive end-expiratory pressure) to prevent alveolar collapse [5]. Recruitment maneuvers during surgery to reopen collapsed alveoli. Furthermore, the use of postoperative nebulizers such as bronchodilator (salbutamol) and steroids has been shown to benefit those patients. Our hypothesis is that intraoperative salbutamol inhaler will lead to a reduction in the incidence and severity of atelectasis especially in diabetic patients. Therefore our primary aim of the study is to examine the incidence of atelectasis in diabetic patients compared to standard anesthesia and surgery techniques in our institution.in addition, outcomes such as severity of the atelectasis, overall hospital stay, side effects of salbutamol, hypoxia and pneumonia.
- Being tested
- Salbutamol (Ventolin®)
- Keywords
- atelectasis, salbutamol, pulmonary, bronchodilator
- Medical subject headings
- Pulmonary Atelectasis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol (Ventolin®)Drug
-4 puffs of salbutamol (each puff = 100 µg, total dose 200-400 µg)
| Study group | Role | What they receive |
|---|---|---|
| salbutamol group for diabetic patients | Experimental | for diabetic patients Receives: Drug: Salbutamol (Ventolin®) |
| no intervention for diabetic | No intervention | Not described |
| salbutamol group for non-diabetic patients | Experimental | for non-diabetic patients Receives: Drug: Salbutamol (Ventolin®) |
| no intervention for non-diabetic patients | No intervention | for non-diabetic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atelectasis (vital signs)
All patients will undergo a thorough medical history, appropriate physical examination, and relevant investigations according to their clinical needs. Particular attention will be given to vital signs, especially pulse oximetry.
Measured: 5 months
Postoperative atelectasis (x-ray)
All patients will undergo a chest X-ray to investigate for atelectasis.
Measured: 5 months
Postoperative atelectasis (blood gases)
Postoperatively blood gases will be assessed to investigate for atelectasis. This will be done through arterial blood gases sample at 24 hours postoperative.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atelectases, Postoperative PulmonaryStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Diab Bani Hani, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591558
- Sponsor's protocol ID
- Apr2026/191-49
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role Intraoperative Salbutamol Inhaler Usage as Part of Intraoperative Regimen in Preventing Atelectasis Following Thoracic, Abdominal and Spinal Surgery in Diabetics Population
- ClinicalTrials.gov ID
- NCT07591558
- Acronym / sponsor ID
- Apr2026/191-49
- Keywords
- atelectasis, salbutamol, pulmonary, bronchodilator
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 May 2026 (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.
Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications, including hypoxemia and pneumonia. In the literature, several methods were utilized to combat this phenomenon, therefore, we investigate the role of intraoperative salbutamol in reducing the incidence of atelectasis. It is well known that salbutamol could be an adjunctive bronchodilator medication used in the intraoperative anesthetic regimens.
Detailed description
Atelectasis is the collapse or incomplete expansion of the lung or a part of it, resulting in impaired gas exchange and potential hypoxemia. It is a common complication in various clinical settings, particularly after surgery, and can contribute to increased morbidity and prolonged hospital stay. The incidence of atelectasis varies widely depending on the patient population and type of surgical procedure. Postoperative atelectasis is reported in up to 90% of patients undergoing general anesthesia, with higher rates observed in thoracic and upper abdominal surgeries. In pediatric populations, the incidence may range from 10-25%, especially following gastrointestinal or thoracic procedures. Key risk factors include general anesthesia, postoperative pain, obesity, advanced age, smoking, prolonged immobility, neuromuscular disorders, and mechanical ventilation. These factors contribute to reduced diaphragmatic motion, impaired mucociliary clearance, and decreased alveolar ventilation. There are several causes of atelectasis in the postoperative period which results from a combination of factors that impair normal lung expansion and ventilation as reduced functional residual capacity as general anesthesia decreases FRC below closing volume, especially in dependent lung areas, promoting alveolar collapse. Impaired diaphragmatic function as pain and muscle relaxation reduce diaphragmatic motion, limiting lung inflation post-surgery. In addition, mucus retention due to suppressed cough reflex and ciliary function leads to resorptive (obstructive) atelectasis. Another important mechanism for atelectasis is airway obstruction and reflex bronchospasm. Management of atelectasis depends mainly on prevention and lung re-expansion strategies and it is divided according to period. In the preoperative period, smoking cessation at least 4-8 weeks before surgery reduces risk and patient education on deep breathing and coughing exercises. In the intraoperative period, the use of lung-protective ventilation as low tidal volumes with adequate PEEP (positive end-expiratory pressure) to prevent alveolar collapse [5]. Recruitment maneuvers during surgery to reopen collapsed alveoli. Furthermore, the use of postoperative nebulizers such as bronchodilator (salbutamol) and steroids has been shown to benefit those patients. Our hypothesis is that intraoperative salbutamol inhaler will lead to a reduction in the incidence and severity of atelectasis especially in diabetic patients. Therefore our primary aim of the study is to examine the incidence of atelectasis in diabetic patients compared to standard anesthesia and surgery techniques in our institution.in addition, outcomes such as severity of the atelectasis, overall hospital stay, side effects of salbutamol, hypoxia and pneumonia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| salbutamol group for diabetic patients | Experimental | Drug: Salbutamol (Ventolin®)for diabetic patients |
| no intervention for diabetic | No intervention | – |
| salbutamol group for non-diabetic patients | Experimental | Drug: Salbutamol (Ventolin®)for non-diabetic patients |
| no intervention for non-diabetic patients | No intervention | –for non-diabetic patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study will include patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status of I or II
- Will undergo thoracic, abdominal or spinal surgery
Key exclusion criteria (2 listed)
- cardiac conditions other than hypertension like arrhythmia
- previous cardiac surgeries and valvular heart diseases
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 |
|---|---|---|
| Salbutamol (Ventolin®)-4 puffs of salbutamol (each puff = 100 µg, total dose 200-400 µg) | Drug | salbutamol group for diabetic patients, salbutamol group for non-diabetic patients |
Primary outcome
Postoperative atelectasis (vital signs)
Time frame: 5 months
All patients will undergo a thorough medical history, appropriate physical examination, and relevant investigations according to their clinical needs. Particular attention will be given to vital signs, especially pulse oximetry.
Postoperative atelectasis (x-ray)
Time frame: 5 months
All patients will undergo a chest X-ray to investigate for atelectasis.
Postoperative atelectasis (blood gases)
Time frame: 5 months
Postoperatively blood gases will be assessed to investigate for atelectasis. This will be done through arterial blood gases sample at 24 hours postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Salbutamol (Ventolin®) in people with Atelectases, Postoperative Pulmonary and Diabete Mellitus, run by King Abdullah University Hospital at 1 site in Jordan.
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 2 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: opening soon, as of the sponsor's last update on 15 May 2026. 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 Jordan. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diab Bani Hani Bani Hani (+962798661232, dabanihani@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative atelectasis (vital signs) (time frame: 5 months). 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?
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 15 May 2026.