- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04458623
Air Test In Diagnosis Of Postoperative Lung Atelectasis
October 26, 2021 updated by: Yasser Mamdouh Hassan Badawy, Assiut University
Accuracy Of Air Test In Diagnosis Of Postoperative Lung Atelectasis In Elderly Patients Undergoing Major Orthopedic Surgery
Postoperative pulmonary complication represent asignificant source of morbidity and have greater incidence and costs than cardiac complications alone .Atelectasis is the commonest one.
Aelectasis may develop in nearly up to 90% of patients after general anaesthesia ,persist up to several days .Oxygen therapy is usually given in the postoperative period to alleviate hypoxemia.
However it's usually discontinued before discharge to the ward based on clinical criteria such as patients being awake with normal vital signs and no respiratory distress.
Available literatures suggest that it's not valid .
Pulse oximetry provide accurate objective measurement of oxygenation,continuous and non invasive.Recently, Fernando etal 2017,used pulse oximetry after 5 minutes of oxygenation to detect postoperative atelectasis, the cut point was 96%.
Study Overview
Detailed Description
Although it has been postulated that early hypoxemia lasts approximately two hours after a surgical procedure, the first 20 minutes of the postoperative period seem to be most critical .
It is evident that the majority of transport times would fall well within this 20 minute window , thus the potential for postoperative hypoxemia during the transport period does exist.
Canet, et al. (1989) found significant differences in oxygen saturation when administering 35% oxygen to adults in the PACU after a 30 second transport while breathing room air.The alveolar shunt induced by atelectasis is the main cause of oxygenation impairment during postoperative period.
Witting MD, Lueck CH reported the ability of pulse oximetry at room air to detect hypoxemia based on 513 blood gas analysis.
Coincidentially a room air oxygen saturation value <96% was selected a cut point of hypoxemia ( Po2 <70 mmhg )and moderate hypercapnia ( Pco2 >50 mmhg ) .
Jones and Jones descriped a digram showing relationship between SPO2 and FiO2 and proved that SPO2 < 96% correspond to shunt effect of more than 10% and defines alveolar collapse .
clark et al 2001determined time required for partial pressure of arterial oxygen to reach equilibrium during mechanical ventilation after a step change in fractional inspired oxygen, they reported that 5-10 minutes will be adequate .
Ferrando C 2017 reported The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery They found that the air test diagnosed postoperative atelectasis with sensitivity of 82% and specificity of 87% and area uder the curve of 0.9 The presence of atelectasis was confirmed by CT scan in all patients with positive air test and in 5 patients with negative air test .The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.Sonography is a simple, noninvasive, and radiation-free methodology which has gained increasing usage in daily practice for detection of atelectasis.
Sonography is a radiation-free methodology which plays an important role in diagnosing pulmonary diseases including obstructive and compressive atelectasis of different origins Furthermore, lung ultrasound has shown reliable sensitivity and specificity for the diagnosis of anaesthesia-induced atelectasis .
Telectasis after general anaesthesia is basal and segmental.
For this,we designed this trial as a pilot to detect the accuracy (sensitivity and specificity) of Air-Test to detect atelectasis in a homogenous group (elderly patients undergoing orthopedic surgery) using Roc testing.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Assiut, Egypt
- faculty of medicine,Assiut university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- - Age (>60 years)
- ASA I , III
- Type of surgery: major orthopedic surgey
Exclusion Criteria:
- -Patient refusal.
- Patients with any significant chest disease
- Patients with any major cardiac disese
- Morbid obese
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: positive air test
postoperative in the recovery room.patients
received supplemental oxygen through a venture mask with a jet and flow adjusted to a theoretical fio2 of 100% for 10 min.
The Air-Test was then performed by removing the oxygen mask and leaving the patients breathing room air for 10 min while continuously monitoring SpO2 with a pulse oximeter finger probe.
The Air-Test result was considered positive when the recorded SpO2 was ≤96%.
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.The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.
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Active Comparator: negative air test
negative when SpO2 was >96 %.
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.The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to assess the accuracy of air test in detecting postoperative atelectasis compared with reference ultrasonographic lung detection of atelectasis in a special grou of patients (aged) and a special form of surgery (orthopedics).
Time Frame: 30 minutes
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using air test
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30 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.
- Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014 Oct 7;3:7. doi: 10.1186/2047-0525-3-7. eCollection 2014.
- Moller JT, Wittrup M, Johansen SH. Hypoxemia in the postanesthesia care unit: an observer study. Anesthesiology. 1990 Nov;73(5):890-5. doi: 10.1097/00000542-199011000-00016.
- Brismar B, Hedenstierna G, Lundquist H, Strandberg A, Svensson L, Tokics L. Pulmonary densities during anesthesia with muscular relaxation--a proposal of atelectasis. Anesthesiology. 1985 Apr;62(4):422-8. doi: 10.1097/00000542-198504000-00009.
- Canet J, Ricos M, Vidal F. Early postoperative arterial oxygen desaturation. Determining factors and response to oxygen therapy. Anesth Analg. 1989 Aug;69(2):207-12.
- Jones JG, Jones SE. Discriminating between the effect of shunt and reduced VA/Q on arterial oxygen saturation is particularly useful in clinical practice. J Clin Monit Comput. 2000;16(5-6):337-50. doi: 10.1023/a:1011495416005.
- Ferrando 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Actual)
October 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
July 1, 2020
First Submitted That Met QC Criteria
July 1, 2020
First Posted (Actual)
July 7, 2020
Study Record Updates
Last Update Posted (Actual)
October 29, 2021
Last Update Submitted That Met QC Criteria
October 26, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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