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

Istanbul University - Cerrahpasa

Status: Not yet enrolling

Conditions: Lung Ultrasonography Score; Recruitment; Postoperative Atelectasis

Treatments: Other: Positional Lung Recruitment Maneuver; Other: Lung Recruitment Maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT07061002

ctf-osas-recruitment-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Single Blind

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66 participants in 3 patient groups

Group 1- control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Lung Recruitment Maneuver

Group 3

Active Comparator group

Description:

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.

Treatment:

Other: Positional Lung Recruitment Maneuver