Lowox

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Vaesterbotten, Umea University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

16 Jan 2025 → ongoing

Decision date (initial)

2024-10-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate if there is an improvement in postoperative arterial oxygen partial pressure (PaO2) after goal-directed low oxygen concentration during anesthesia compared to the routine use with fixed oxygen concentrations.

Secondary objectives 8

1. If there is an improvement in oxygen transport measured as the diffusion capacity for carbon monoxide (DLCO) after goal-directed low oxygen concentration during anesthesia compared to the routine use with fixed oxygen concentrations.
2. Whether there is an improvement in vital capacity (lung function) and postoperative recovery after goal-directed low oxygen concentration during anesthesia compared to the routine use with fixed oxygen concentrations.
3. If there is a difference in change in arterial carbon dioxide partial pressure (PaCO2) with regard to the randomization.
4. If there is a difference in change in arterial oxygen partial pressure (PaO2) on postoperative day (POD) 1 and after 3 months with regard to the randomization.
5. If there is a difference in surgical site infections with regard to randomization.
6. If there is a difference in postoperative recovery with regard to randomization
7. If there is a difference in hospital length of stay with regard to randomization.
8. If background variables (age, sex, BMI, type of surgery, duration of surgery, and type of anesthesia) affect outcomes.

Conditions and MedDRA coding

Surgery under general anesthesia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adults (> 18 years old)
2. The subject has given their written consent to participate in the trial.
3. Be scheduled for abdominal surgery performed at the Departments of Surgery, Urology and Gynecology lasting more than 2 hours.
4. Fall under the American Society of Anesthesia (ASA) Class 1-3.

Exclusion criteria 5

1. Increased risk for difficult intubation during anesthesia (Mallampati score 3-4) or previous documentation of difficult intubation.
2. The inability to understand written or verbal information, thereby hindering the ability to provide informed consent.
3. Obese with a BMI >35 kg/m2.
4. Participation or recent participation within 30 days in a clinical trial with an investigational medicinal product. Previous participation in this trial.
5. Pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.

Secondary endpoints 7

1. Change in diffusion capacity for carbon monoxide on day 2 and after 3 months compared to the day preceding surgery (=baseline).
2. Change in vital capacity (VC) on day 2 and after 3 months compared to baseline.
3. Change in PaO2 and PaCO2 on day 1 and after 3 months compared to baseline.
4. Surgical site infections within 30 days of surgery.
5. Postoperative recovery using the Postoperative Recovery Profile at discharge and after 3 months
6. Hospital length of stay.
7. Effect of background variables on outcomes, including age, sex, height, weight, body mass index (BMI), type of surgery, duration of surgery, and type of anesthesia.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Vaesterbotten

Sponsor organisation

Region Vaesterbotten

Address

Koksvagen 11, Alidhem Alidhem

City

Umea

Postcode

907 37

Country

Sweden

Scientific contact point

Organisation

Region Vaesterbotten

Contact name

Karl Franklin

Public contact point

Organisation

Region Vaesterbotten

Contact name

Karl Franklin

Umea University

Sponsor organisation

Umea University

Address

Universitetstorget 4, Alidhem Alidhem

City

Umea

Postcode

907 36

Country

Sweden

Scientific contact point

Organisation

Umea University

Contact name

Magnus Hultin

Public contact point

Organisation

Umea University

Contact name

Magnus Hultin

Sponsor responsibilities

Article 77 compliance

Region Vaesterbotten

Contact point sponsor

Region Vaesterbotten

Article 77 implementation

Region Vaesterbotten

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications