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The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis

Primary Purpose

Pulmonary Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Recruitment maneuver
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Atelectasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >18 years old
  • Laporoscopic nephrectomy patients who will be operated in lateral positions
  • Elective, semi-elective surgeries

Exclusion Criteria:

  • Patients with emphysema
  • Patients with documanted heart failure
  • Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia
  • Patients with hemodynamic instability
  • Patients with pneumothorax risk
  • Emergency surgery
  • Patients requiring intraoperative liberal fluid therapy (>10 cc/kg/hr)
  • Patients requiring blood products

Sites / Locations

  • Istanbul University Istanbul Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group RM

Group NoRM

Arm Description

One single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation

Usual care will be applied in this group

Outcomes

Primary Outcome Measures

Comparison of the pre-extubation LUS scores (T3)
Lung ultrasound will be applied in each group to observe the lungs' condition (atelectasis,consolidation...) and understand the effect of a "single" recruitment maneuver. To obtain LUS score; each lobe is examined on 6 different areas which will be scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).

Secondary Outcome Measures

Comparison of recovery room LUS scores (T4)
Lung ultrasound will be applied at post-extubation 30th minute to evaluate the compare the groups for the possible effect of single RM. To obtain LUS score; each lobe is examined on 6 different areas which are scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
Comparison of recovery room PaO2
Arterial blood gas will be analyzed at post-extubation 30th minute along with LUS to observe the effect of RM on oxygenation
The effect of deltaLUS (T3-T2) on oxygenation
DeltaLUS values will be analyzed for relation with post-extubation 30th min PaO2 values.
Length of stay in post anesthesia care unit (PACU)
The duration required for the patient to stay in PACU (minutes)
Length of stay in hospital
The duration required for patient to stay in hospital (days)
Postoperative respiratory complications
Incidence of mild-to-severe respiratory failure, pneumothorax, ALI, ARDS, bronchospasm, pneumonia
Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications
Sensitivity and specifity (Area under the curve-ROC analysis) values of LUS score of dependant lung. (0=the best condition of the dependant lung, 18=the worst condition of the dependant lung with consolidation and atelectasis)

Full Information

First Posted
August 6, 2022
Last Updated
May 4, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05494255
Brief Title
The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis
Official Title
The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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
Laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. Lung Ultrasound Scoring (LUS) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. In this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (RM) just before emergence and extubation (at the end of surgery) on LUS scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. Accordingly, the intervention group will be applied single RM before extubation, while the control group will be awaken without RM. There will be LUS evaluation at 4 different time for intervention group (Group RM) points that are: T1: 5 min after the intubation T2: At the end of surgery (After skin closure, before recruitment maneuver) T3(RM): After recruitment maneuver, before extubation T4: 30 minutes after extubation in the recovery room LUS evaluation will be made at 3 different time points in control group (Group NoRM): T1: 5 min after the intubation T3(NoRM): Before extubation (no recruitment maneuvers will be made) T4: 30 minutes after extubation in the recovery room. The primary outcome is the comparison of the T3 LUS scores. Assuming a 40% difference in the T3 LUS score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. A possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group. Secondary outcomes will include; difference in T4 LUS scores, the effect of RM on postoperative recovery room oxygenation, and the effect of deltaLUS (T3-T2) on postoperative recovery room oxygenation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group RM
Arm Type
Active Comparator
Arm Description
One single recruitment maneuver will be applied in this group at the end of the surgery and before the extubation
Arm Title
Group NoRM
Arm Type
No Intervention
Arm Description
Usual care will be applied in this group
Intervention Type
Other
Intervention Name(s)
Recruitment maneuver
Intervention Description
In Group RM (intervention group) after skin closure, mechanical ventilation settings will be set to FiO2:100%, I:E=1:1, respiratory rate: 6, and then tidal volume will be increased gradually by 150 ml until reaching a plato pressure of 30 mmHg. After 3 breaths in this state, RM will be considered accomplished. LUS evaluation will be made just before and after the RM.
Primary Outcome Measure Information:
Title
Comparison of the pre-extubation LUS scores (T3)
Description
Lung ultrasound will be applied in each group to observe the lungs' condition (atelectasis,consolidation...) and understand the effect of a "single" recruitment maneuver. To obtain LUS score; each lobe is examined on 6 different areas which will be scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
Time Frame
Up to 4 hours
Secondary Outcome Measure Information:
Title
Comparison of recovery room LUS scores (T4)
Description
Lung ultrasound will be applied at post-extubation 30th minute to evaluate the compare the groups for the possible effect of single RM. To obtain LUS score; each lobe is examined on 6 different areas which are scored from 0 to 3, and both lungs will be evaluated. Therefore maximum score may change from 0 (no atelectasis, best condition) to 36 (worst condition, broad atelectasis and consolidation).
Time Frame
Up to 4.5 hours
Title
Comparison of recovery room PaO2
Description
Arterial blood gas will be analyzed at post-extubation 30th minute along with LUS to observe the effect of RM on oxygenation
Time Frame
Up to 4.5 hours
Title
The effect of deltaLUS (T3-T2) on oxygenation
Description
DeltaLUS values will be analyzed for relation with post-extubation 30th min PaO2 values.
Time Frame
Up to 4.5 hours
Title
Length of stay in post anesthesia care unit (PACU)
Description
The duration required for the patient to stay in PACU (minutes)
Time Frame
Up to 4 hours
Title
Length of stay in hospital
Description
The duration required for patient to stay in hospital (days)
Time Frame
Up to 2 weeks
Title
Postoperative respiratory complications
Description
Incidence of mild-to-severe respiratory failure, pneumothorax, ALI, ARDS, bronchospasm, pneumonia
Time Frame
Up to 5 days
Title
Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications
Description
Sensitivity and specifity (Area under the curve-ROC analysis) values of LUS score of dependant lung. (0=the best condition of the dependant lung, 18=the worst condition of the dependant lung with consolidation and atelectasis)
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18 years old Laporoscopic nephrectomy patients who will be operated in lateral positions Elective, semi-elective surgeries Exclusion Criteria: Patients with emphysema Patients with documanted heart failure Patients requiring intraoperative multiple recruitment maneuver due to hypoxemia Patients with hemodynamic instability Patients with pneumothorax risk Emergency surgery Patients requiring intraoperative liberal fluid therapy (>10 cc/kg/hr) Patients requiring blood products
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared upon reasonable request

Learn more about this trial

The Effects of Pre-extubation Single Recruitment Maneuver on Perioperative Atelectasis

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