Chronic Obstructive Pulmonary Disease (COPD)OXYCOPD-ICUNCT07842510
Controlled Versus Standard Oxygen Therapy in ICU Patients With Acute Exacerbation of COPD
A study testing Standard oxygen therapy in people with Chronic Obstructive Pulmonary Disease (COPD) and Acute Exacerbation of COPD, run by Hôpital Universitaire Taher Sfar at 2 sites in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Acute Exacerbation of COPD, Intensive Care Unit (ICU)
- What is being tested?
- Standard oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesTunisia
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia2 sites, 2 recruiting
- Not yet recruiting
Dhouha Ben Braiek
Kairouan
Dhouha Ben Braiek, Assistant Professor of Medical, +21650523823, bbraiek.dhouha@gmail.com
Dhouha Ben Braiek, Assistant Professor
- Recruiting
Taher Sfar Mahdia Hospital
Mahdia, Mahdia Governorate, 5100
Mohamed Fekih Hassen, Professor, +21622987642, mohamed.fekihhassen1@gmail.com
Hajer Nouira, Associate professor, +21622858699, nouirahajer@gmail.com
About this study
Official title: Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial
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
- Being tested
- Controlled oxygen therapy, Standard oxygen therapy
- Keywords
- COPD; Acute exacerbation; Controlled oxygen therapy; Mechanical ventilation; Intensive care unit.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled oxygen therapyOther
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 therapyOther
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%.
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: 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%. Receives: Other: Standard oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization
Secondary outcomes (3)
Mortality at Day 28
Measured: Day 28 after randomization
Length of stay in the intensive care unit
Measured: From randomization until ICU discharge or death, up to 28 days
Requirement for invasive mechanical ventilation
Measured: From randomization until ICU discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Taher Sfar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hajer Nouira, Hôpital Universitaire Taher Sfar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842510
- Sponsor's protocol ID
- OXYCOPD-ICU-01
- Acronym
- OXYCOPD-ICU
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Controlled Versus Standard Oxygen Therapy Strategy in ICU Patients With Acute Exacerbation of COPD: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842510
- Acronym / sponsor ID
- OXYCOPD-ICU / OXYCOPD-ICU-01
- 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.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hôpital Universitaire Taher SfarOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled oxygen therapy group | Experimental | Other: Controlled oxygen therapyControlled 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%). |
| Standard oxygen therapy group: | Active comparator | Other: Standard oxygen therapyStandard oxygen therapy group: Oxygen will be administered according to the unit's usual practice, targeting an SpO₂ >94%. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled oxygen therapyOxygen 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%. | Other | Controlled oxygen therapy group |
| Standard oxygen therapyOxygen therapy will be administered according to the usual practice of the intensive care unit and adjusted to maintain peripheral oxygen saturation (SpO₂) above 94%. | Other | Standard oxygen therapy group: |
Primary outcome
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.
3 secondary outcomes
Mortality at Day 28
Time frame: Day 28 after randomization
Length of stay in the intensive care unit
Time frame: From randomization until ICU discharge or death, up to 28 days
Requirement for invasive mechanical ventilation
Time frame: From randomization until ICU discharge or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard oxygen therapy in people with Chronic Obstructive Pulmonary Disease (COPD) and Acute Exacerbation of COPD, run by Hôpital Universitaire Taher Sfar at 2 sites in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hajer Nouira (+21622858699, nouirahajer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of mechanical ventilation (time frame: From randomization until definitive discontinuation of mechanical ventilation Up to 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.