Patients With ASA Status I-III Scheduled for Elective SurgeryNCT02650037
The Air Test: A New Simple, Non-invasive Method to Diagnose Anesthesia-induced Atelectasis
An observational study of Patients With ASA Status I-III Scheduled for Elective Surgery, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Anesthesia-induced atelectasis persist in the postoperative period but are not usually diagnosed because imaging techniques are required. The aim of the study is to determine whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we defined as the Air Test, was able to diagnose… 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 Elective Surgery
- What is being tested?
- Air Test
- Type of treatment
- Surgery or procedure
- How many people
- 181 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Nov 2015
- 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 all patients with ASA status I-III scheduled for elective surgery.
Who may be able to join
- ASA I-III
- Scheduled for elective surgery
Who cannot join
- age of <18 years
- pregnant women
- previous lung resection
- local-regional anesthesia
- cardio-thoracic anesthesia
- preoperative room air SpO2 less than 97%
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Anesthesia and Critical Care; Hospital Clinico Universitario
Valencia, Valencia, 46010
About this study
Official title: Estudio de validación de la pulsioximetría Como método diagnóstico no Invasivo de Atelectasia Pulmonar y de la Efectividad de la Maniobra de Capacidad Vital Para la reversión de la Atelectasia Durante el Postoperatorio
Anesthesia-induced atelectasis persist in the postoperative period but are not usually diagnosed because imaging techniques are required. The aim of the study is to determine whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a general anesthesia.
- 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 on arrival into the postoperative anesthesia care unit 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.
Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography.
After arrival to the post-surgery unit, patients received supplemental oxygen through a venturi mask with flow adjusted to approximate a FiO2 of 0.5 during the first 30 minutes. The SpO2 measure was made removing the oxygen mask and leaving the patients to breath room air for at least for 5 minutes.
Measured: 35 minutes post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients With ASA Status I-III Scheduled for Elective 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
- 181 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
- NCT02650037
- Sponsor's protocol ID
- AirTest
- Status last verified
- Jan 2016
- First submitted
- 28 Dec 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.
PubMed 23385321Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.
PubMed 12821566Hedenstierna G, Tokics L, Strandberg A, Lundquist H, Brismar B. Correlation of gas exchange impairment to development of atelectasis during anaesthesia and muscle paralysis. Acta Anaesthesiol Scand. 1986 Feb;30(2):183-91. doi: 10.1111/j.1399-6576.1986.tb02393.x.
PubMed 3085429Ferrando 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 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio de validación de la pulsioximetría Como método diagnóstico no Invasivo de Atelectasia Pulmonar y de la Efectividad de la Maniobra de Capacidad Vital Para la reversión de la Atelectasia Durante el Postoperatorio
- ClinicalTrials.gov ID
- NCT02650037
- Acronym / sponsor ID
- AirTest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
Anesthesia-induced atelectasis persist in the postoperative period but are not usually diagnosed because imaging techniques are required. The aim of the study is to determine whether the value of SpO2≤96 while breathing room air (0.21 FiO2) for 5 min, maneuver that we defined as the Air Test, was able to diagnose atelectasis in the postoperative period after a general anesthesia.
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 all patients with ASA status I-III scheduled for elective surgery.
Key inclusion criteria (2 listed)
- ASA I-III
- Scheduled for elective surgery
Key exclusion criteria (6 listed)
- age of <18 years
- pregnant women
- previous lung resection
- local-regional anesthesia
- cardio-thoracic anesthesia
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 on arrival into the postoperative anesthesia care unit while measuring peripheral oxygen saturation by Pulse oximetry | Procedure or surgery | – |
Primary outcome
Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography.
Time frame: 35 minutes post-surgery
After arrival to the post-surgery unit, patients received supplemental oxygen through a venturi mask with flow adjusted to approximate a FiO2 of 0.5 during the first 30 minutes. The SpO2 measure was made removing the oxygen mask and leaving the patients to breath room air for at least for 5 minutes.
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 8 Jan 2016.
- Background: PubMed 23385321Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.
- Background: PubMed 12821566Magnusson L, Spahn DR. New concepts of atelectasis during general anaesthesia. Br J Anaesth. 2003 Jul;91(1):61-72. doi: 10.1093/bja/aeg085. No abstract available.
- Background: PubMed 3085429Hedenstierna G, Tokics L, Strandberg A, Lundquist H, Brismar B. Correlation of gas exchange impairment to development of atelectasis during anaesthesia and muscle paralysis. Acta Anaesthesiol Scand. 1986 Feb;30(2):183-91. doi: 10.1111/j.1399-6576.1986.tb02393.x.
- Derived from this study: 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.
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.
1 site 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 Elective Surgery, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site 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 2 inclusion and 6 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Presence of postoperative atelectasis meassured by SpO2 levels and confirmed by computed tomography. (time frame: 35 minutes post-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 NCT02650037, which also lists 4 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 8 Jan 2016.