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Air Test In Diagnosis Of Postoperative Lung Atelectasis

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Air Test
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atelectasis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • faculty of medicine,Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

positive air test

negative air test

Arm Description

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%.

negative when SpO2 was >96 %.

Outcomes

Primary Outcome Measures

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).
using air test

Secondary Outcome Measures

Full Information

First Posted
July 1, 2020
Last Updated
October 26, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04458623
Brief Title
Air Test In Diagnosis Of Postoperative Lung Atelectasis
Official Title
Accuracy Of Air Test In Diagnosis Of Postoperative Lung Atelectasis In Elderly Patients Undergoing Major Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
positive air test
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
negative air test
Arm Type
Active Comparator
Arm Description
negative when SpO2 was >96 %.
Intervention Type
Diagnostic Test
Intervention Name(s)
Air Test
Intervention Description
.The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis.
Primary Outcome Measure Information:
Title
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).
Description
using air test
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
faculty of medicine,Assiut university
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25313335
Citation
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.
Results Reference
background
PubMed Identifier
2240679
Citation
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.
Results Reference
background
PubMed Identifier
3885791
Citation
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.
Results Reference
background
PubMed Identifier
2764289
Citation
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.
Results Reference
background
PubMed Identifier
12580217
Citation
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.
Results Reference
background
PubMed Identifier
28554935
Citation
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.
Results Reference
background
PubMed Identifier
24662376
Citation
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.
Results Reference
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Air Test In Diagnosis Of Postoperative Lung Atelectasis

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