Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD

NCT07842510 | Recruiting

• 1 other identifier: OXYCOPD-ICU-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Acute exacerbations frequently require intensive care unit (ICU) admission. Oxygen therapy is an essential component of treatment; however, excessive oxygen administration may aggravate hypercapnia and respiratory acidosis. Current international guidelines recommend titrated oxygen therapy targeting an oxygen saturation of 88-92% in patients with acute exacerbation of COPD, but evidence supporting this strategy in critically ill ICU patients remains limited. This randomized controlled trial aims to compare a controlled oxygen therapy strategy (target oxygen saturation 88-92%) with standard oxygen therapy (oxygen saturation \>94%) in ICU patients admitted with acute exacerbation of COPD. The primary objective is to determine whether controlled oxygen therapy reduces the duration of mechanical ventilation (invasive and non-invasive). Secondary objectives include assessing the 28-day mortality, ICU length of stay, the need for invasive mechanical ventilation, and adverse events related to hyperoxia.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Acute Exacerbation of COPD; Intensive Care Unit (ICU); Controlled Oxygen Therapy; Mechanical Ventilation Complication

Keywords

COPD; Acute exacerbation; Controlled oxygen therapy; Mechanical ventilation; Intensive care unit.

Outcome Measures

Primary Outcomes (1)

• Total duration of mechanical ventilation

  Total cumulative duration of mechanical ventilation, defined as the sum of the duration of non-invasive ventilation and invasive mechanical ventilation.

  From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization

Secondary Outcomes (3)

• Mortality at Day 28

  Day 28 after randomization

• Length of stay in the intensive care unit

  From randomization until ICU discharge or death, up to 28 days

• Requirement for invasive mechanical ventilation

  From randomization until ICU discharge or death

Study Arms (2)

Controlled oxygen therapy group

EXPERIMENTAL

Controlled oxygen therapy group: Oxygen will be administered using an adjustable delivery device (nasal cannula, Venturi mask, or heated high-flow humidified oxygen) to maintain an Sp-92% oxygen saturation (SpO-92%).

Other: Controlled oxygen therapy

Standard oxygen therapy group:

ACTIVE COMPARATOR

Standard oxygen therapy group: Oxygen will be administered according to the unit's usual practice, targeting an SpO₂ \>94%.

Other: Standard oxygen therapy

Interventions

Controlled oxygen therapy OTHER

Oxygen therapy will be administered using an adjustable oxygen delivery device, including nasal cannula, Venturi mask, or high-flow nasal oxygen, and titrated to maintain peripheral oxygen saturation (SpO₂) between 88% and 92%.

Controlled oxygen therapy group

Standard oxygen therapy OTHER

Oxygen therapy will be administered according to the usual practice of the intensive care unit and adjusted to maintain peripheral oxygen saturation (SpO₂) above 94%.

Standard oxygen therapy group:

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• Established diagnosis of chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
• Admission to the intensive care unit for an acute exacerbation of COPD, with or without respiratory acidosis
• Written informed consent provided by the participant or their legally authorized representative

You may not qualify if:

• Endotracheal intubation performed before enrollment
• Severe decompensated heart failure with a left ventricular ejection fraction \< 30%
• Active terminal malignancy
• Refusal to participate in the study

Sponsors & Collaborators

• Hôpital Universitaire Taher Sfar: lead

Study Sites (2)

Taher Sfar Mahdia Hospital

Mahdia, Mahdia Governorate, 5100, Tunisia

RECRUITING

Dhouha Ben Braiek

Kairouan, Tunisia

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hajer Nouira

CONTACT

+21622858699; nouirahajer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Intensive Care Medicine

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 25, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)