Postoperative ComplicationsNCT04895527
Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery
An observational study of Postoperative Complications, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial summary
One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 30 Jun 2024
- 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: Patients undergoing scheduled laparoscopic surgery will be included and informed consent will be asked to perform air-test postoperatively.
Who may be able to join
- patients undergoing scheduled laparoscopic surgery
Who cannot join
- Pregnant or lactating women.
- Presence of moderate to severe acute respiratory distress.
- Patients suffering from heart failure.
- Patients undergoing invasive mechanical ventilation during the 15 days prior to surgery.
- Patients with a history of cardiothoracic surgery
Trial locations and contacts
1 site in 1 country.
About this study
One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis.
A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery.
Read more
Secondary objectives:
- Measure the incidence of positive results in the air-test.
- Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
- Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.
Read the detailed description
The persistence of postsurgical atelectasis is potentially associated with complications such as pneumonia, acute respiratory distress, and hypoxemia. This promotes other systemic complications such as myocardial ischemia or healing defects, negatively affecting morbidity, healthcare costs, and postoperative survival. Pre and intraoperative hemoglobin saturation levels are an independent risk factor for postoperative pulmonary complications. The airtest, based on the measurement of peripheral oxygen saturation (SpO2) with ambient air in the early postoperative period, is a useful tool in the prevention of moderate-severe pulmonary postsurgical complications.
One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis.
A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, parameters, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery at the Doctor Negrín University Hospital of Gran Canaria.
Secondary objectives:
- Measure the incidence of positive results in the air-test.
- Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
- Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.
- Conditions
- Postoperative Complications
- Keywords
- airtest, atelectasis, postoperative period, complications
- Medical subject headings
- Postoperative Complications, Pulmonary Atelectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
to demonstrate the veracity of the air-test in the prevention of pulmonary complications in patients undergoing scheduled laparoscopic surgery
Measured: 30 days postoperatively
Postoperative systemic complications
to demonstrate the veracity of the air-test in the prevention of systemic complications in patients undergoing scheduled laparoscopic surgery
Measured: 30 days postoperatively
Secondary outcomes (2)
Incidence of positive air-test
to detect the prevalence of patients showing positive in the air-test in the postoperative period after scheduled laparoscopic surgery
Measured: 4 hours postoperatively
Recruitment maneuvers and air-test
to demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
Measured: from the intraoperative period (recruitment maneuvers) until 4 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Ángel, MD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895527
- Sponsor's protocol ID
- Airtest-Negrín
- Status last verified
- Jul 2024
- First submitted
- 17 May 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data can be available after request to the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04895527
- Acronym / sponsor ID
- Airtest-Negrín
- Conditions
- Postoperative Complications
- Keywords
- airtest, atelectasis, postoperative period, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 May 2021 (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.
One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis.
A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery.
Secondary objectives:
- Measure the incidence of positive results in the air-test.
- Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
- Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.
Detailed description
The persistence of postsurgical atelectasis is potentially associated with complications such as pneumonia, acute respiratory distress, and hypoxemia. This promotes other systemic complications such as myocardial ischemia or healing defects, negatively affecting morbidity, healthcare costs, and postoperative survival. Pre and intraoperative hemoglobin saturation levels are an independent risk factor for postoperative pulmonary complications. The airtest, based on the measurement of peripheral oxygen saturation (SpO2) with ambient air in the early postoperative period, is a useful tool in the prevention of moderate-severe pulmonary postsurgical complications.
One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis.
A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, parameters, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery at the Doctor Negrín University Hospital of Gran Canaria.
Secondary objectives:
- Measure the incidence of positive results in the air-test.
- Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test
- Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.
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
- Patients undergoing scheduled laparoscopic surgery will be included and informed consent will be asked to perform air-test postoperatively.
Key inclusion criteria (1 listed)
- patients undergoing scheduled laparoscopic surgery
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Presence of moderate to severe acute respiratory distress.
- Patients suffering from heart failure.
- Patients undergoing invasive mechanical ventilation during the 15 days prior to surgery.
- Patients with a history of cardiothoracic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative pulmonary complications
Time frame: 30 days postoperatively
to demonstrate the veracity of the air-test in the prevention of pulmonary complications in patients undergoing scheduled laparoscopic surgery
Postoperative systemic complications
Time frame: 30 days postoperatively
to demonstrate the veracity of the air-test in the prevention of systemic complications in patients undergoing scheduled laparoscopic surgery
2 secondary outcomes
Incidence of positive air-test
Time frame: 4 hours postoperatively
Recruitment maneuvers and air-test
Time frame: from the intraoperative period (recruitment maneuvers) until 4 hours postoperatively
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 24 Jul 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data can be available after request to the principal investigator
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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. This study is not recruiting at the moment.
Ángel Ángel, MD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
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 Postoperative Complications, run by Hospital Universitario de Gran Canaria Doctor Negrín 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 1 inclusion and 5 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 24 Jul 2024. 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?
Postoperative pulmonary complications (time frame: 30 days postoperatively). The study lists 2 primary outcomes in all. 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 24 Jul 2024.