Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207819349638 Date of Registration: 25/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparative study between using lung ultrasonography and fiber-optic bronchoscopy for detection of proper endotracheal tube position in intubated patients in intensive care unit
Official scientific title A comparative study between using lung ultrasonography and fiber-optic bronchoscopy for detection of proper endotracheal tube position in intubated patients in intensive care unit
Brief summary describing the background and objectives of the trial Bronchial intubations occur in 5% to 15% of cases in both prehospital and inpatient settings. These intubations may remain unrecognized in 6% to 25% of cases. The position of the endotracheal tube (ETT) may also be affected by patient movement from the Trendelenburg position or other maneuvers that raise the diaphragm. Single-lung intubation leads to both immediate and downstream complications. First, suboptimal ventilation and oxygenation will occur without gas exchange in the contralateral lung. Second, barotrauma from large volumes may also result in pneumothorax, and unilateral pulmonary edema may also develop. Third, unnecessary thoracostomy for presumed pneumothorax may even be performed when simple, slight ETT retraction would have sufficed. Auscultation has been the standard for determining ETT location and was recommended by institutions such as the American Heart Association as well as major Anesthesiology and Perioperative Care text books. However, the use of auscultation to distinguish between tracheal and bronchial intubation has been shown to be unreliable, with a reported sensitivity of only 60 to 65%. Ultrasonography is quick and inexpensive, and it is already readily available in the clinical areas where endotracheal intubation occurs. Recent evidence has supported the use of ultrasound for the detection of esophageal versus tracheal intubations with reported sensitivity/ specificity of 100% for adult patients in the operating room and 100%/86%, respectively, in patients undergoing cardiopulmonary resuscitation. The primary objective of this study is to estimate the sensitivity of lung ultrasonography for detection of proper endotracheal tube position in comparison to fiber optic bronchoscopy in intubated patients in intensive care unit.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 05/12/2020
Actual trial start date 01/01/2021
Anticipated date of last follow up 20/06/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lung ultrasound no dose used once placement of the linear probe on the left and right anterior chest walls, approximately at the third rib space mid-clavicular line, to ascertain the presence of the pleural sliding sign or absence of the pleural sliding sign via both two dimensional and M-mode modalities 60
Control Group fiberoptic bronchoscopy once once fob is done o detect endobronchial and endotracheal intubation after proper sedation and musclle relaxtaion according to patients condition 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- patients who were intubated during their stay in the intesnsive care unit. - Age more than 18 years old. - BMI less than 33 Patients with surgical emphysema at chest . Patients on high inotropic support Patients with any lung pathology that would affect the study technique such as pneumothorax, emphysema and mesothelioma. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/12/2020 Research Ethical Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lung ultrasound sensitivity in detecting inadverent endobonchial intubation. just after the examination
Secondary Outcome sensitivity of auscultaion in detecting inadverent endobronchial intubation. just after the examinaion is finished
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university ramsees street cario 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omar sayed osman No. 8 Hassan ibrahim, naser city cairo 4450113 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor omar sayed nasr city cairo 4450113 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar Sayed Osman Hassan Ibrahim st. naser city cairo 4450113 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator omar sayed omar_sayed90@hotmail.com 01001451974 nasr city
City Postal code Country Position/Affiliation
cairo 4450113 Egypt assistant lecturer ain shams university
Role Name Email Phone Street address
Public Enquiries Waleed Abdallah drwalidabdullah@yahoo.com 01223198866 hadayek el qobba
City Postal code Country Position/Affiliation
cairo Egypt Professor at Anesthesia Department Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries thabet aziz thabet1604@yahoo.com 01222886650 abassya
City Postal code Country Position/Affiliation
cairo Egypt lecturer at Anesthesia Department Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial, after de-identification Study Protocol Following publication Any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information