to Detect the Incidence of AtelectasisNCT03144310
To Evaluate the Role of Lung Ultrasonography for Detection of Atlelectasis in Robot Assisted Laproscopic Pelvic Sugeries
An observational study of to Detect the Incidence of Atelectasis, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- to Detect the Incidence of Atelectasis
- What is being tested?
- lung ultrasound
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to Nov 2017
- How long will I take part?
- 1 Day
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA Iand II age 18-70 yrs
Who may be able to join
- ASA Iand II age 18-70 yrs robot assisted pelvis surgeries
Who cannot join
- ASA II and IV cardiac and lung disease
About this study
Official title: TO EVALUATE THE ROLE OF LUNG ULTRASONOGRAPHY FOR DETECTION OF ATELECTASIS IN ADULTS UNDERGOING ROBOT ASSISTED LAPAROSCOPIC PELVIC SURGERIES
Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis
Read the detailed description
Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis inclusion criteria: age 18 to 70 yrs age ASA I and II robot assisted pelvic surgeries in steep trendelenburg position
exclusion criteria: cardiac disese severe obstructive and restrictive disease upper airways infection ASAIII and IV
- Conditions
- to Detect the Incidence of Atelectasis
- Being tested
- lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundOther
Also called blood gas analysis
lung ultrasound and blood gas
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of atelectasis
incidence of atelectasis in adults after extubation undergoing robot assisted pelvic laproscopic surgery in steep trendelenberg position using ultrasound
Measured: 24hrs
Secondary outcomes (1)
risk factor identification
risk factor identification of post operative atelectasis
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Nov 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Detect the Incidence of AtelectasisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Rahul Kathuria, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Pgimer, Study chair, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144310
- Sponsor's protocol ID
- NK/3067/MD/320
- Status last verified
- Dec 2017
- First submitted
- 4 May 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TO EVALUATE THE ROLE OF LUNG ULTRASONOGRAPHY FOR DETECTION OF ATELECTASIS IN ADULTS UNDERGOING ROBOT ASSISTED LAPAROSCOPIC PELVIC SURGERIES
- ClinicalTrials.gov ID
- NCT03144310
- Acronym / sponsor ID
- NK/3067/MD/320
- Conditions
- to Detect the Incidence of Atelectasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 May 2017 (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.
Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis
Detailed description
Pre op ultrasound with chest auscultation and arterial blood gas, after extubation ultrasound with chest auscultation and blood gas, 12hrs chest auscultation with ultasaound, 24 hrs chest auscultation and ultrasound to see atelectasis inclusion criteria: age 18 to 70 yrs age ASA I and II robot assisted pelvic surgeries in steep trendelenburg position
exclusion criteria: cardiac disese severe obstructive and restrictive disease upper airways infection ASAIII and IV
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA Iand II age 18-70 yrs
Key inclusion criteria (1 listed)
- ASA Iand II age 18-70 yrs robot assisted pelvis surgeries
Key exclusion criteria (1 listed)
- ASA II and IV cardiac and lung disease
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 |
|---|---|---|
| lung ultrasoundAlso: blood gas analysislung ultrasound and blood gas | Other | – |
Primary outcome
incidence of atelectasis
Time frame: 24hrs
incidence of atelectasis in adults after extubation undergoing robot assisted pelvic laproscopic surgery in steep trendelenberg position using ultrasound
1 secondary outcome
risk factor identification
Time frame: 24hrs
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 3 Jan 2018.
- Individual participant dataSharing planned: No
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.
Pgimer study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
Questions about this trial
What is this clinical trial studying?
An observational study of to Detect the Incidence of Atelectasis, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 1 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 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
incidence of atelectasis (time frame: 24hrs). 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 3 Jan 2018.