Effects of Permissive Hypercapnia During Lung Surgery on Inflammatory Biomarkers in Serum and Bronchoalveolar Lavage Fluid

NCT07749456 | Completed

• 1 other identifier: 3856/ and12-3102-1/2-2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective was to evaluate the effects of permissive hypercapnia on inflammatory biomarkers in bronchoalveolar lavage fluid and serum during one-lung ventilation. The secondary objective was to assess the influence of different ventilation modes on these inflammatory responses. Methods: Forty patients undergoing elective lung surgery requiring OLV were prospectively enrolled an allocated to either a normocapnic (n=20) or hypercapnic group group (n=20). BAL concentrations of TNF-α, IL-1β, IL-6, and IL-8 were measured before and after intervention. Serum IL-6, C-reactive protein (CRP), and leukocyte counts were also assessed. Patients were further stratified according to ventilation mode (PC or VC). Outcome measures: Primary outcome: change of bronchoalveolar lavage (BAL) levels of preselected biomarkers for inflammation (TNF-α , IL-1β, IL-6, and IL-8) as well as in serum (IL-6, CRP, and WBC) between the normocapnic and hypercapnic groups during one-lung ventilation. Secondary outcome: whether the inflammatory response differed according to the ventilation mode (pressure-controlled versus volume-controlled ventilation).

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Effect of permissive hypercapnia on the inflammatory response during one-lung ventilation

  The primary outcome of the study was to evaluate the effect of permissive hypercapnia on the inflammatory response during one-lung ventilation by comparing a prespecified panel of inflammatory biomarkers between the normocapnic and hypercapnic groups. The primary outcome measures included BAL concentrations of TNF-α , IL-1β, IL-6, and IL-8, together with serum IL-6, CRP, and WBC count, measured at predefined sampling time points.

  After induction of anesthesia and at the end of surgery

Study Arms (2)

Permissive hypercapnia group

EXPERIMENTAL

The permissive hypercapnia during one-lung ventilation was used. The target CO2 values were 55-75momHg. Then the patients were divided into volume-controlled mode of ventilation or pressure-controlled mode.

Other: Allowed permissive hypercapnia

Normocapnic group

ACTIVE COMPARATOR

Normocapnia during protective one-lung ventilation was used. And the patients were further divided in volume-controlled or pressure-controlled mode of ventilation

Other: Allowed permissive hypercapnia

Interventions

Allowed permissive hypercapnia OTHER

Normocapnic group; Permissive hypercapnia group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants were aged 18-85 years,
• classified as American Society of Anesthesiologists (ASA) physical status I-III, --scheduled for procedures expected to last at least 60 minutes, with anticipated OLV for the the majority of the intraoperative period.

You may not qualify if:

• body mass index (BMI) \> 35 kg/m2;
• impaired pulmonary function (vital capacity of forced expiratory volume in 1 second (FEV1) \< 50% of predicted values);
• chronic infection;
• intracranial hypertension;
• prior intracranial hemorrhage;
• presence of active extrapulmonary malignancy;
• chronic pulmonary diseases (including chronic pneumonia, pneumoconiosis and silicosis);
• pulmonary hypertension;
• severe chronic obstructive pulmonary disease (COPD) with chronic hypercapnia;
• patients undergoing bilobectomy or pneumonectomy

Sponsors & Collaborators

• University of Nis: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist in anesthesia, resuscitation and intensive care

Model Details: Randomization was performed in two consecutive stages using sequentially num-bered, opaque, sealed envelope. In the first stage, patients were randomly allocated in a 1:1 ratio to the normocapnia (n=20) or the hypercapnia group (n=20). In the second stage, patients within each group were further randomized in a 1:1 ratio to receive either pres-sure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) using the same allocation procedure.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 6, 2026
• Study Start: June 1, 2015
• Primary Completion: February 20, 2026
• Study Completion: February 28, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share