Perioperative Hyperoxia vs Normoxia Biomarker Trial

NCT07525661 | Completed

• 1 other identifier: 2017/771
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center randomized interventional study evaluated the biological effects of two perioperative oxygen strategies in adults undergoing elective laparoscopic lower abdominal surgery under standardized general anesthesia. Participants were assigned to receive either normoxia (FiO2 0.35) or hyperoxia (FiO2 0.80) after intubation and throughout the intraoperative period. The study assessed perioperative changes in circulating biomarkers related to pulmonary epithelial stress, endothelial glycocalyx injury, oxidative stress, and inflammation, together with blood gas and hemodynamic parameters. The study was completed before registration and is being registered retrospectively.

Conditions

Hyperoxia; Oxidative Stress; Endothelial Glycocalyx Injury; Perioperative Care

Keywords

Hyperoxia; Normoxia; Perioperative Oxygen Therapy; Syndecan-1; Sialic Acid; Surfactant Protein-A; TNF-alpha; Randomized Trial

Outcome Measures

Primary Outcomes (6)

• Concentration of syndecan-1

  Serum syndecan-1 concentration measured in duplicate.

  10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

• Concentration of sialic acid

  Serum sialic acid concentration measured in duplicate.

  10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

• Concentration of surfactant protein-A

  Serum surfactant protein-A concentration measured in duplicate.

  10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

• Concentration of ischemia-modified albumin

  Serum ischemia-modified albumin concentration measured in duplicate.

  10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

• Concentration of TNF-alpha

  Serum TNF-alpha concentration measured in duplicate.

  10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

• Concentration of total protein

  Serum total protein concentration measured in duplicate.

  10 minutes after establishment of assigned oxygen fraction and immediately after surgery/post-extubation

Secondary Outcomes (12)

• Arterial oxygen tension (PaO2)

  10 minutes after establishment of assigned oxygen fraction

• Intraoperative mean arterial pressure

  Immediately after intubation and every 15 minutes up to 90 minutes

• Intraoperative heart rate

  Immediately after intubation and every 15 minutes up to 90 minutes

• Arterial oxygen tension (PaO2)

  10 minutes after establishment of assigned oxygen fraction

• Arterial pH

  10 minutes after establishment of assigned oxygen fraction

Study Arms (2)

Normoxia

EXPERIMENTAL

Intraoperative inspired oxygen fraction (FiO2) of 0.35 under standardized general anesthesia and volume-controlled ventilation.

Other: Perioperative Oxygen Strategy - Normoxia

Hyperoxia

EXPERIMENTAL

Intraoperative inspired oxygen fraction (FiO2) of 0.80 under standardized general anesthesia and volume-controlled ventilation.

Other: Perioperative Oxygen Strategy-Hyperoxia

Interventions

Perioperative Oxygen Strategy-Hyperoxia OTHER

Hyperoxia arm: FiO2 0.80 Intervention started immediately after intubation and maintained intraoperatively

Hyperoxia

Perioperative Oxygen Strategy - Normoxia OTHER

Normoxia arm: FiO2 0.35 Intervention started immediately after intubation and maintained intraoperatively

Normoxia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 70 years
• Scheduled for elective laparoscopic lower abdominal surgery
• Expected surgery duration of at least 90 minutes
• ASA physical status I to III
• Body mass index 18.5 to 35 kg/m2
• Planned management under standardized general anesthesia with volume-controlled ventilation

You may not qualify if:

• Known chronic pulmonary disease, including chronic obstructive pulmonary disease or asthma requiring regular medication
• Baseline peripheral oxygen saturation below 92% on room air
• Significant cardiovascular instability
• Severe hepatic or renal dysfunction
• Active infection or systemic inflammatory disease
• Use of systemic corticosteroids or immunosuppressive therapy
• Pregnancy
• Inability to provide informed consent
• Anticipated difficult airway
• Expected need for postoperative mechanical ventilation

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Lopez MG, Pandey AK, Hennessy C, Hughes CG, Absi TS, Shah AS, Shotwell MS, Harrison DG, Billings FT 4th; ROCS Trial Investigators. Effects of Oxygen on Perioperative Vascular Function: A Randomized Clinical Trial. J Am Heart Assoc. 2025 Aug 5;14(15):e041778. doi: 10.1161/JAHA.125.041778. Epub 2025 Jul 17.

  PMID: 40673571 BACKGROUND

• Farag E, Esa Y, Chehade NEH, Sleiman VB, Seif J. Endothelial glycocalyx in perioperative medicine current understanding and future direction. J Clin Anesth. 2026 Mar;110:112154. doi: 10.1016/j.jclinane.2026.112154. Epub 2026 Feb 16.

  PMID: 41702329 BACKGROUND

• Larvin J, Edwards M, Martin DS, Feelisch M, Grocott MPW, Cumpstey AF. Perioperative oxygenation-what's the stress? BJA Open. 2024 Mar 20;10:100277. doi: 10.1016/j.bjao.2024.100277. eCollection 2024 Jun.

  PMID: 38545565 BACKGROUND

• Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.

  PMID: 19826023 BACKGROUND

• Elfeky A,Chen YF,Grove A,Couper K,Court R,Tomassini S,Wilson A,Hooper A,Buckle A,Vadeyar S,Thompson M,Uthman O,Yeung J

  BACKGROUND

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Nuzhet Mert Senturk

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: July 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)