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

NCT07061002 | Not Yet Recruiting

• 1 other identifier: ctf-osas-recruitment-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Atelectasis; Lung Ultrasonography Score; Recruitment

Keywords

Postoperative Pulmonary Atelectases; lung ultrasound score; recruitment maneuver

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Pulmonary Complications with Different Recruitment Maneuver Techniques

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

Study Arms (3)

Group 1- control

NO INTERVENTION

The 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 2

ACTIVE COMPARATOR

The 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.

Other: Lung Recruitment Maneuver

Group 3

ACTIVE COMPARATOR

The 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.

Other: Positional Lung Recruitment Maneuver

Interventions

Lung Recruitment Maneuver OTHER

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.

Group 2

Positional Lung Recruitment Maneuver OTHER

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.

Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

Istanbul, 34153, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 31523784 RESULT

• 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.

  PMID: 21544025 RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ayse Cigdem Tutuncu, Professor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  STUDY CHAIR

• Munevver Kayhan, Lecturer Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  PRINCIPAL INVESTIGATOR

• Pinar Kendigelen, Professor Doctor

  Istanbul University-Cerrahpasa, Cerrahpasa Medicine of Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Munevver Kayhan, Lecturer Doctor

CONTACT

+905057983044; munevver.kayhan@iuc.edu.tr

Ayse Cigdem Tutuncu, Professor Doctor

CONTACT

+905325920584; actutuncu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: After participants are enrolled and informed consent is obtained, they will be randomly assigned to one of three groups in a 1:1:1 ratio using a computer-generated randomization list prepared by an independent anesthesiologist who is not involved in the intervention. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes for each patient. To maintain double blinding, both the patients and the researchers responsible for postoperative evaluations (including those performing lung ultrasound and clinical follow-ups) will remain unaware of group assignments. The intraoperative team responsible for performing the intervention will only carry out the assigned procedure and will not be involved in data collection, evaluation, or analysis. Group assignments will be documented separately and kept confidential until the study is completed and data analysis is finalized.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)