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Completed

NCT Number: NCT05494255

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

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.

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Key information

Conditions

Pulmonary Atelectasis Lung Diseases Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recruitment maneuver

Other

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 outcomes

  1. Comparison of the pre-extubation LUS scores (T3)

    Time frame: Up to 4 hours

    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 outcomes

  1. Comparison of recovery room LUS scores (T4)

    Time frame: Up to 4.5 hours

    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).

  2. Comparison of recovery room PaO2

    Time frame: Up to 4.5 hours

    Arterial blood gas will be analyzed at post-extubation 30th minute along with LUS to observe the effect of RM on oxygenation

  3. The effect of deltaLUS (T3-T2) on oxygenation

    Time frame: Up to 4.5 hours

    DeltaLUS values will be analyzed for relation with post-extubation 30th min PaO2 values.

  4. Length of stay in post anesthesia care unit (PACU)

    Time frame: Up to 4 hours

    The duration required for the patient to stay in PACU (minutes)

  5. Length of stay in hospital

    Time frame: Up to 2 weeks

    The duration required for patient to stay in hospital (days)

  6. Postoperative respiratory complications

    Time frame: Up to 5 days

    Incidence of mild-to-severe respiratory failure, pneumothorax, ALI, ARDS, bronchospasm, pneumonia

  7. Predictive value of dependant lung T3 (preextubation) LUS score detecting postoperative pulmonary complications

    Time frame: Up to 24 hours

    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)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Effects of Pre-extubation Single Recruitment Maneuver on Lung Ultrasound Scores and Postoperative Oxygenation in Laparoscopic Nephrectomy Surgeries

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2022
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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