Patients With ASA Status I-III Scheduled for SurgeryNCT03469648
Intraoperative Air-Test
An observational study of Patients With ASA Status I-III Scheduled for Surgery, run by Fundación para la Investigación del Hospital Clínico de Valencia at 2 sites in Spain.
Trial summary
Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With ASA Status I-III Scheduled for Surgery
- What is being tested?
- Air-Test
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 2 sitesSpain
- Study dates
- 10 Mar 2018to 20 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included consecutive patients who were scheduled for surgery with general anesthesia and mechanical ventilation
Who may be able to join
- American Society of Anesthesiologist (ASA) I-IV
- General Anesthesia
- Mechanical ventilation
Who cannot join
- age < 18 years old
- pregnancy
- patients undergoing cardiothoracic surgery
- ASA physical status V
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Carlos Ferrando
Valencia, 46010
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Valencia, 46010
About this study
Official title: Incidence of Intraoperative Positive Air-Test
Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse.
The aim of this study is to non-invasively describe the incidence of intraoperative atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt to describe the association between positive Air-Test and the patient´s preoperative or intraoperative variables.
- Being tested
- Air-Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-TestProcedure or surgery
The Air Test simply consisted in breathing room air for 5 min during anesthesia while measuring peripheral oxygen saturation by Pulse oximetry
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with positive Air-Test
Positive Air-Test defined as SpO2 < 97% while breathing room air
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start10 Mar 2018
- Primary completion10 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients With ASA Status I-III Scheduled for SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Ferrando, Fundación para la Investigación del Hospital Clínico de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469648
- Sponsor's protocol ID
- Air-Test
- Status last verified
- Oct 2018
- First submitted
- 7 Mar 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferrando C, Tusman G, Suarez-Sipmann F, Leon I, Pozo N, Carbonell J, Puig J, Pastor E, Gracia E, Gutierrez A, Aguilar G, Belda FJ, Soro M. Individualized lung recruitment maneuver guided by pulse-oximetry in anesthetized patients undergoing laparoscopy: a feasibility study. Acta Anaesthesiol Scand. 2018 May;62(5):608-619. doi: 10.1111/aas.13082. Epub 2018 Jan 29.
PubMed 29377061Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosda R, Valls P, Villena A, Serralta F, Jurado A, Carrizo J, Navarro J, Parrilla C, Romero JE, Pozo N, Soro M, Villar J, Belda FJ. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study. BMJ Open. 2017 May 29;7(5):e015560. doi: 10.1136/bmjopen-2016-015560.
PubMed 28554935
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Intraoperative Positive Air-Test
- ClinicalTrials.gov ID
- NCT03469648
- Acronym / sponsor ID
- Air-Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 19 Mar 2018 (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.
Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse.
The aim of this study is to non-invasively describe the incidence of intraoperative atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt to describe the association between positive Air-Test and the patient´s preoperative or intraoperative variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included consecutive patients who were scheduled for surgery with general anesthesia and mechanical ventilation
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist (ASA) I-IV
- General Anesthesia
- Mechanical ventilation
Key exclusion criteria (4 listed)
- age < 18 years old
- pregnancy
- patients undergoing cardiothoracic surgery
- ASA physical status V
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 |
|---|---|---|
| Air-TestThe Air Test simply consisted in breathing room air for 5 min during anesthesia while measuring peripheral oxygen saturation by Pulse oximetry | Procedure or surgery | – |
Primary outcome
Patients with positive Air-Test
Time frame: During surgery
Positive Air-Test defined as SpO2 < 97% while breathing room air
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Background: PubMed 29377061Ferrando C, Tusman G, Suarez-Sipmann F, Leon I, Pozo N, Carbonell J, Puig J, Pastor E, Gracia E, Gutierrez A, Aguilar G, Belda FJ, Soro M. Individualized lung recruitment maneuver guided by pulse-oximetry in anesthetized patients undergoing laparoscopy: a feasibility study. Acta Anaesthesiol Scand. 2018 May;62(5):608-619. doi: 10.1111/aas.13082. Epub 2018 Jan 29.
- Background: PubMed 28554935Ferrando C, Romero C, Tusman G, Suarez-Sipmann F, Canet J, Dosda R, Valls P, Villena A, Serralta F, Jurado A, Carrizo J, Navarro J, Parrilla C, Romero JE, Pozo N, Soro M, Villar J, Belda FJ. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study. BMJ Open. 2017 May 29;7(5):e015560. doi: 10.1136/bmjopen-2016-015560.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With ASA Status I-III Scheduled for Surgery, run by Fundación para la Investigación del Hospital Clínico de Valencia at 2 sites in Spain.
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 3 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: finished, as of the sponsor's last update on 2 Oct 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with positive Air-Test (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469648, which also lists 2 linked publications.
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 2 Oct 2018; AzTrials last refreshed its copy on 28 Oct 2026.