IRCT | Evaluating the effectiveness of caffeine on blood gases and short-term hospital outcomes in patients with acute COPD exacerbation requiring NIV in patients referred to Bahonar Emergency Department.

Protocol summary

Study aim: To evaluate the effect of caffeine on arterial blood gas parameters and short-term clinical outcomes in patients with acute exacerbation of COPD requiring non-invasive ventilation (NIV).
Design: Randomized, double-blind, placebo-controlled, parallel-group trial. Block randomization (blocks of 4 and 6) with computer-generated sequence. 140 patients (70 per group).
Settings and conduct: Setting: Emergency department and internal medicine ward, Bahonar Hospital, Karaj, Iran. Patients with acute COPD exacerbation requiring NIV will be randomly assigned to intervention or control. Double-blind design (patients and outcome assessor blinded). ABG parameters (pH, PCO2, PO2) and O2 saturation measured at baseline and daily for 5 days. Clinical outcomes (intubation, hospital/ICU stay, mortality) recorded.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Age 40-85 years, acute exacerbation of COPD, NIV indication (respiratory acidosis: pH≤7.35, PaCO2≥45 mmHg or severe dyspnea with respiratory muscle fatigue). Exclusion criteria: Immediate intubation need, hemodynamic instability, decreased consciousness, facial abnormalities preventing mask fit, recent thoracic/abdominal surgery, cardiac arrhythmias, caffeine hypersensitivity, pregnancy, breastfeeding, concurrent trial participation.
Intervention groups: Intervention group: Standard COPD exacerbation treatment + NIV + oral caffeine 200 mg twice daily for 5 days. Control group: Standard COPD exacerbation treatment + NIV + placebo twice daily for 5 days.
Main outcome variables: Primary outcomes: 1. Change in arterial blood gas parameters (pH, PaCO2 [mmHg], PaO2 [mmHg]) from baseline to day 5, measured daily. 2. Change in O2 saturation (%) from baseline to day 5, measured daily by pulse oximetry. Time points: Baseline and daily at 8:00 AM for 5 days

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20250430065541N1

Registration date: 2026-02-27, 1404/12/08

Registration timing: prospective

Last update: 2026-02-27, 1404/12/08

Update count: 0
Registration date: 2026-02-27, 1404/12/08

Registrant information: Name

Nasim Barjaste

Name of organization / entity

Alborz University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 26 3255 5000

Email address

nasimbarjaste@gmail.com

Recruitment status: recruiting
Funding source

Expected recruitment start date: 2026-04-04, 1405/01/15
Expected recruitment end date: 2026-07-06, 1405/04/15
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Evaluating the effectiveness of caffeine on blood gases and short-term hospital outcomes in patients with acute COPD exacerbation requiring NIV in patients referred to Bahonar Emergency Department.

Public title: Effect of caffeine in COPD
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

COPD patients who meet the criteria for COPD exacerbation (presence of any of the symptoms of worsening shortness of breath, increased sputum volume, increased sputum viscosity) COPD exacerbation patient who requires NIV during an attack Absence of contraindications to NIV placement (trauma or facial deformity, severe decreased level of consciousness, abundant pulmonary secretions, high risk of aspiration, cardiorespiratory arrest) Patient consents to participate in the study4 Age 40 to 85 years

Exclusion criteria:

1. Patient over 85 years of age Pregnancy History of caffeine sensitivity Patient unwillingness to participate in the study Decreased level of consciousness Facial or chest deformity Asthma Neuromuscular diseases and chest disorders Pneumothorax Persistent and frequent vomiting Intolerance to NIV for any reason Occurrence of caffeine side effects
Age: From 40 years old to 85 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor

Sample size

Target sample size: 70

Randomization (investigator's opinion)

Randomized

Randomization description

Patients eligible for the study will be determined and 70 of them will be selected as available. Based on a random number table, they will be randomly divided into two intervention and control groups (each group includes 35 people) using a random block permutation method with blocks of size 4 (Random allocation).

Blinding (investigator's opinion)

Double blinded

Blinding description

This study is designed as a double-blind study. - The caffeine and placebo capsules will be identical in shape, size, color, and packaging. - One person will be responsible for preparing, coding, and randomly distributing the containers based on the randomization list. - Participants, treating physicians, nurses, and researchers assessing clinical outcomes will be unaware of the contents of the capsules.

Placebo

Used

Assignment

Parallel

Other design features

Randomized, double-blind, placebo-controlled, parallel-group clinical trial. Randomization will be performed using block randomization method with block sizes of 4 and 6, using a computer-generated random number sequence. The study includes 140 patients (70 in each group) with acute exacerbation of COPD requiring non-invasive ventilation (NIV).

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Alborz University of Medical Sciences

Street address

Alborz University of Medical Sciences(ABZUMS), Taleghani Boulevard, Taleghani square

City

Karaj

Province

Alborz

Postal code

3149779453
Approval date: 2026-02-15, 1404/11/26
Ethics committee reference number: IR.ABZUMS.REC.1404.352

Health conditions studied

1

Description of health condition studied: Chronic obstructive pulmonary disease
ICD-10 code: J44.1
ICD-10 code description: Chronic obstructive pulmonary disease with (acute) exacerbation

Primary outcomes

1

Description: Change in arterial partial pressure of carbon dioxide (PaCO2) from baseline to day 5
Timepoint: Baseline (before intervention) and daily at 8:00 AM for 5 consecutive days
Method of measurement: Measured using a calibrated arterial blood gas analyzer from arterial blood samples

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Caffeine tablets 200 mg orally every 12 hours for 5 days
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Bahonar Hospital

Full name of responsible person

Nasim Barjaste

Street address

Esteghlal Boulevard, Janbazan

City

Karaj

Province

Alborz

Postal code

3154686695

Phone

+98 914 560 0782

Email

nasimbarjaste@gmail.com

1

Sponsor: Name of organization / entity

Alborz University of Medical Sciences

Full name of responsible person

Deputy of research and technology, Alborz University of Medical Sciences

Street address

North Taleghani Boulevard

City

Karaj

Province

Alborz

Postal code

3149969415

Phone

+98 26 3419 7000

Email

nasimbarjaste@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Alborz University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Karaj University of Medical Sciences

Full name of responsible person

Somayeh Rezaian

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Internal Medicine

Street address

Taleghani Boulevard,Taleghani square

City

Karaj

Province

Alborz

Postal code

3149779453

Phone

+98 26 3419 7000

Email

somaye.rezaian@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Karaj University of Medical Sciences

Full name of responsible person

Somayeh Rezaian

Position

Associate professor

Latest degree

Subspecialist

Other areas of specialty/work

Internal Medicine

Street address

Taleghani Boulevard,Taleghani square

City

Karaj

Province

Alborz

Postal code

3149779453

Phone

+98 26 3256 3318

Email

somaye.rezaian@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Karaj University of Medical Sciences

Full name of responsible person

Nasim Barjasteh

Position

Resident (Internal Medicine)

Latest degree

Medical doctor

Other areas of specialty/work

Internal Medicine

Street address

Taleghani Boulevard,Taleghani square

City

Karaj

Province

Alborz

Postal code

3149779453

Phone

+98 26 3419 7000

Email

nasimbarjasteh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: De-identified individual participant data (IPD) including demographic characteristics, arterial blood gas parameters (PH, PCO2, PO2), O2 saturation, Borg scale scores, intubation rates, length of hospital stay, ICU admission, and NIV duration.
When the data will become available and for how long: Immediately after publication of the main study results (expected by 2027). No end date.
To whom data/document is available: Researchers and clinicians affiliated with academic and scientific institutions who provide a methodologically sound proposal and sign a data access agreement.
Under which criteria data/document could be used: For individual participant data meta-analysis, secondary analyses related to COPD exacerbation, respiratory physiology, or effects of caffeine on respiratory outcomes. Data should only be used for non-commercial scientific research purposes with proper citation of the original study.
From where data/document is obtainable: Corresponding author: Dr. Somayeh Rezaian, Assistant Professor, Department of Internal Medicine, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran. Email: somaye.rezaian@gmail.com Alternative contact: Nasim Barjasteh (Principal researcher), Email: nasimbarjasteh@gmail.com, Tel: +98 914 560 0782
What processes are involved for a request to access data/document: Interested researchers should submit a formal request via email to the corresponding author, including a brief research proposal and intended use of data. The proposal will be reviewed by the study team within 2-4 weeks. If approved, a data sharing agreement must be signed before data transfer. De-identified data will be provided electronically within 4-6 weeks after agreement finalization.
Comments: Data will be shared in compliance with Alborz University of Medical Sciences ethics guidelines and Iranian national regulations for research data sharing. The study was approved by the ethics committee with reference ID: IR.ABZUMS.REC.1404.352 and registered in IRCT with tracking code: 890.

Evaluating the effectiveness of caffeine on blood gases and short-term hospital outcomes in patients with acute COPD exacerbation requiring NIV in patients referred to Bahonar Emergency Department.