Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07842510

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taher Sfar Mahdia Hospital, Mahdia, Mahdia Governorate, Tunisia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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%.

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%.

Primary outcomes

  1. Total duration of mechanical ventilation

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

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

Secondary outcomes

  1. Mortality at Day 28

    Time frame: Day 28 after randomization

  2. Length of stay in the intensive care unit

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

  3. Requirement for invasive mechanical ventilation

    Time frame: From randomization until ICU discharge or death

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Taher Sfar

Other Gov

Registry information

Official study title

Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial

Acronym: OXYCOPD-ICU

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.