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Postoperative AtelectasisNCT07061002

Evaluation of Recruitment Effectiveness in Patients With Obstructive Sleep Apnea Syndrome Using Lung Ultrasound

A study testing Lung Recruitment Maneuver and Positional Lung Recruitment Maneuver in people with Postoperative Atelectasis and Lung Ultrasonography Score, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Patients with obstructive sleep apnea syndrome are at higher risk for respiratory complications after surgery. Oxygen depletion and respiratory distress are common in patients with obstructive sleep apnea syndrome. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Lung Recruitment Maneuver and Positional Lung Recruitment Maneuver
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jul 2025to 1 Jul 2026
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-65
  • American Society of Anesthesia I-III
  • Patients with consent to participate
  • Patients with preoperative OSA diagnosis (polysomnography or STOP-BANG≥3)

Who cannot join

  • American Society of Anesthesia >IV
  • Patients planned for postoperative intensive care follow-up 3. Cardiac surgery
  • Anesthesia outside the operating room
  • History of neuromuscular disease
  • Emergency surgical application
  • Invasive airway surgeries (pharynx, larynx)
  • Lung surgeries (pneumonectomy, lobectomy, etc.) 9. Presence of pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Munevver Kayhan, Lecturer Doctor contact

+905057983044

munevver.kayhan@iuc.edu.tr

Ayse Cigdem Tutuncu, Professor Doctor contact

+905325920584

actutuncu@gmail.com

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

    Istanbul, 34153

Other trials in Turkey (Türkiye)

About this study

Patients with obstructive sleep apnea syndrome are at higher risk for respiratory complications after surgery. Oxygen depletion and respiratory distress are common in patients with obstructive sleep apnea syndrome. In this study, the effectiveness of the recruitment maneuver applied in the postoperative period will be investigated via lung ultrasound. Recruitment is a technique performed to improve the oxygen levels of patients. Patients diagnosed with obstructive sleep apnea syndrome between the ages of 18-65 will be included in the study and anesthesia and surgical procedures will be followed. The aim of the study is to compare the pulmonary complication rates between patients who underwent recruitment and those who did not, and to examine the effects of factors such as age and gender on these complications via lung ultrasound.

Read the detailed description

The effect of the recruitment maneuver applied in the postoperative period on lung ventilation and atelectasis will be investigated via lung ultrasound. Recruitment is a technique performed to improve the oxygen levels of patients. Patients diagnosed with obstructive sleep apnea between the ages of 18-65 will be included in the study. The aim of the study is to compare atelectasis rates, pleural fascial fluid accumulation, lung compliance, pneumothorax findings between patients who underwent and did not undergo recruitment with lung ultrasound. In addition, to examine the effects of factors such as age and gender on these complications with lung ultrasound. Our study is a prospective, single-center, control group clinical trial to be conducted on patients diagnosed with obstructive sleep apnea syndrome (OSA). Patients between the ages of 18-65, classified as American Society of Anesthesia I-III, and diagnosed with Obstructive Sleep Apnea (polysomnography or STOP-BANG score ≥3) will be included in the study. Written informed consent will be obtained from the patients before the surgical procedure. Patients to be excluded from the study will include American Society of Anesthesia class IV and above patients, those with a history of neuromuscular disease, patients requiring cardiac surgery, and patients requiring urgent surgical intervention.

Patients will be randomly divided into three groups by computer-based program: Group 1: A fixed 5 cmH2O post expiratory positive end-expiratory pressure will be applied. Group 2: In addition to the fixed positive end-expiratory pressure, a recruitment maneuver will be performed at the end of surgery before extubation by giving 6 breaths with a tidal volume at 2 times the vital capacity, an inspiration/expiration ratio of 1/1, and a lung plateau pressure of < 35 cmH2O. Group 3: In addition to the fixed positive end-expiratory pressure, a recruitment maneuver will be performed at the end of surgery by giving 6 breaths in the right and left lateral decubitus positions before extubation. All patients' preoperative demographic data, apnea device usage, chest X-ray, total anesthesia duration, surgical duration, drugs used and their doses, ventilation parameters (tidal volume, positive end-expiratory pressure, airway peak pressure), fluid balance, surgical procedure type, patient position data will be recorded. Hemodynamic parameters, oxygen, respiratory exercise and bronchodilator requirements of patients taken to the recovery unit will be recorded. Lung A line and B line scores will be evaluated separately as 8 zones while performing lung ultrasonography of all patients. Plasm points, air bronchogram findings, pleural sliding movements will be recorded for each zone. In these follow-ups, saturation, hemodynamic parameters, respiratory exercise, bronchodilator requirement, intubation requirement, unplanned intensive care admission, hospital stay duration will also be recorded.

Being tested
Lung Recruitment Maneuver, Positional Lung Recruitment Maneuver
Keywords
Postoperative Pulmonary Atelectases, lung ultrasound score, recruitment maneuver
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung Recruitment ManeuverOther

    Lung Recruitment Maneuver (LRM) is a method that allows the alveoli to reopen by applying high positive pressure in order to prevent or treat alveolar collapse (atelectasis) that develops during or after anesthesia. LRM improves oxygenation by increasing functional residual capacity. Clinical studies have shown that LRM increases oxygenation levels, reduces areas of atelectasis, and shortens hospital stay. In this study, the effects of different recruitment maneuvers on postoperative atelectasis will be evaluated. In this group, just before extubation, the patients in this group will be given 6 breaths with a tidal volume of 2 times the vital capacity, an inspiratory/expiratory ratio of 1/1 and a lung plateau pressure of < 35 cmH2O, and a recruitment maneuver will be performed at the end of the surgery.

  • Positional Lung Recruitment ManeuverOther

    Lung Recruitment Maneuver (LRM) is a method that allows the alveoli to reopen by applying high positive pressure in order to prevent or treat alveolar collapse (atelectasis) that develops during or after anesthesia. LRM improves oxygenation by increasing functional residual capacity. Clinical studies have shown that LRM increases oxygenation levels, reduces areas of atelectasis, and shortens the length of hospital stay. In this study, the effects of different recruitment maneuvers on postoperative atelectasis will be evaluated. Patients in this group will be placed in the right and then left lateral decubitus position before extubation at the end of surgery and a recruitment maneuver will be performed by giving 6 breaths in each position, with a tidal volume twice the vital capacity, a 1/1 inspiratory/expiratory ratio, and a lung plateau pressure < 35 cmH2O.

Study groups in NCT07061002
Study groupRoleWhat they receive
Group 1- controlNo interventionThe patient will be ventilated throughout the surgery by applying 5 cmH2O post expiratory positive end-expiratory pressure. Lung ultrasound will be performed on the patients before surgery, 5 minutes after mechanical ventilation after orotracheal intubation, at the end of surgery and 5 minutes after extubation. The lung will be evaluated in 8 regions. These will be evaluated as upper and lower in the mid-clavicular line, upper and lower in the anterior axillary line, upper and lower in the posterior axillary line and Plaps point. It will be evaluated by calculating the modified Lung Ultrasound Score (LUSS) to detect ventilation loss. Higher scores in LUSS indicate more severe ventilation loss. The degree of deaeration will be evaluated between 0 and 3. , 0 less than 3 B line; ≥3 B lines indicate 1, greater than 5 and confluent B lines indicate 2, and multiple confluent B lines or multiple subpleural consolidations separated by a thickened or irregular pleural line indicate 3.
Group 2Active comparatorThe ventilation strategy of the patients in this group will be the same as in group 1. In contrast, just before extubation, the patients in this group will be given 6 breaths with a tidal volume of 2 times the vital capacity, an inspiratory/expiratory ratio of 1/1 and a lung plateau pressure of < 35 cmH2O, and a recruitment maneuver will be performed at the end of the surgery. All patients will undergo lung ultrasound in the defined lung zones and at the specified times, as described in group 1, and a modified Lung Ultrasound score will be evaluated.
Receives: Other: Lung Recruitment Maneuver
Group 3Active comparatorThe ventilation strategy of the patients in this group will be the same as in group 1. In addition to positive end-expiratory pressure, the patient will be placed in the right and then left lateral decubitus position before extubation at the end of the surgery and a recruitment maneuver will be performed by giving 6 breaths in each position with a tidal volume twice the vital capacity, a 1/1 inspiratory/expiratory ratio and a lung plateau pressure < 35 cmH2O. All patients will undergo lung ultrasound in defined lung regions and at specified times, as defined in group 1, and a modified Lung Ultrasound score will be evaluated.
Receives: Other: Positional Lung Recruitment Maneuver

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pulmonary complications underwent recruitment maneuver

    The primary outcome of the study was to compare the pulmonary complication rates between patients who underwent the recruitment maneuver and those who did not by lung ultrasound. Pulmonary complications were assessed by using the modified lung ultrasound score (LUSS). Higher scores on the LUSS indicated more severe ventilation loss. The degree of deaeration was assessed from 0 to 3. , Less than 3 B lines; ≥3 B lines were rated as 1, greater than 5 and confluent B lines were rated as 2, and multiple confluent B lines separated by a thickened or irregular pleural line or multiple subpleural consolidations were rated as 3.

    Measured: 10 minutes before the start of surgery until 10 minutes after the end of surgery

Secondary outcomes (1)
  1. Pulmonary Complications with Different Recruitment Maneuver Techniques

    The secondary outcome is to compare the pulmonary complication rates between patients who received different recruitment maneuver techniques. To compare the postoperative pulmonary complication rates of parameters such as age, gender, and body mass index. Pulmonary complications will be assessed by performing the modified lung ultrasound score (LUSS). Higher scores on the LUSS indicate more severe ventilation loss. The degree of deaeration will be assessed from 0 to 3. , Less than 3 B lines; ≥3 B lines indicate 1, greater than 5 and confluent B lines indicate 2, and multiple confluent B lines separated by thickened or irregular pleural lines or multiple subpleural consolidations indicate 3.

    Measured: 10 minutes before the start of surgery until 10 minutes after the end of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start25 Jul 2025 (estimated)
  3. Primary completion20 Jun 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Crossover
Masking
Single blind
Who is masked
Care provider
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061002
Sponsor's protocol ID
ctf-osas-recruitment-01
Status last verified
Jul 2025
First submitted
2 Jul 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Touw HR, Schuitemaker AE, Daams F, van der Peet DL, Bronkhorst EM, Schober P, Boer C, Tuinman PR. Routine lung ultrasound to detect postoperative pulmonary complications following major abdominal surgery: a prospective observational feasibility study. Ultrasound J. 2019 Sep 16;11(1):20. doi: 10.1186/s13089-019-0135-6.

    PubMed 31523784
  • Canet J, Hardman J, Sabate S, Langeron O, Abreu MG, Gallart L, Belda J, Markstaller K, Pelosi P, Mazo V. PERISCOPE study: predicting post-operative pulmonary complications in Europe. Eur J Anaesthesiol. 2011 Jun;28(6):459-61. doi: 10.1097/EJA.0b013e328344be2d. No abstract available.

    PubMed 21544025

Questions about this trial

What is this clinical trial studying?

A study testing Lung Recruitment Maneuver and Positional Lung Recruitment Maneuver in people with Postoperative Atelectasis and Lung Ultrasonography Score, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

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: opening soon, as of the sponsor's last update on 11 Jul 2025. 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 Turkey (Türkiye). 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?

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 Munevver Kayhan, Lecturer Doctor (+905057983044, munevver.kayhan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pulmonary complications underwent recruitment maneuver (time frame: 10 minutes before the start of surgery until 10 minutes after the end of surgery). 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 NCT07061002, which also lists 2 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 11 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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