Imran Technique for Spinal Anesthesia and Lumbar Puncture (IMRAN-LP)
2026年6月3日 更新者：Wah Medical college , POF hospital
Imran's Approach: A Quasi-Experimental Prospective Comparative Study of an Alternative Positioning Technique for Spinal Anesthesia and Lumbar Puncture
This quasi-experimental prospective clinical trial was conducted to compare the conventional sitting position with the Imran Technique, a novel ergonomic patient-positioning method, for spinal anesthesia and lumbar puncture.
A total of 200 adult participants requiring spinal anesthesia for surgical procedures or diagnostic lumbar puncture were allocated into two groups.
The study aimed to evaluate procedural success, procedural efficiency, patient comfort, operator ergonomics, and procedure-related complications associated with the two positioning techniques.
調査の概要
詳細な説明
This quasi-experimental prospective clinical trial was designed to compare the conventional sitting position and the Imran Technique during spinal anesthesia and lumbar puncture procedures. Adult participants aged 18 to 65 years who required spinal anesthesia for surgical procedures or diagnostic lumbar puncture were enrolled and allocated into two groups.
Participants in the control group underwent the procedure using the conventional sitting position, while participants in the intervention group underwent the procedure using the Imran Technique. The primary outcome measure was first-attempt procedural success. Secondary outcome measures included total procedural time, positioning-to-needle insertion time, number of needle attempts, needle redirections, intervertebral space changes, overall procedural success, need for operator assistance, patient comfort, ability to maintain position, operator strain, accessibility of the intervertebral space, and procedure-related complications.
The study was conducted at the Intensive Care Unit of the Department of Anaesthesiology, POF Hospital, Wah Cantt, Pakistan, following Institutional Review Board approval and written informed consent procedures.
研究の種類
介入
入学 (実際)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Punjab Province
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Wah、Punjab Province、パキスタン、4070
- Wah Medical College, POF Hospital Wah cantt
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adult participants aged 18 to 65 years
- Participants requiring spinal anesthesia for surgical procedures or diagnostic lumbar puncture
- Participants medically suitable for spinal anesthesia or lumbar puncture
- Participants able to assume and maintain the assigned procedural position
- Participants who provided written informed consent
Exclusion Criteria:
- Age below 18 years or above 65 years
- Previous spinal surgery
- Significant spinal deformity
- Local infection at the puncture site
- Coagulopathy or bleeding disorders
- Raised intracranial pressure
- Severe hemodynamic instability
- Inability to maintain the assigned procedural position
- Refusal to participate or inability to provide informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Conventional Sitting Position
Participants underwent spinal anesthesia or lumbar puncture using the conventional sitting position according to standard institutional practice.
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Standard sitting patient positioning used for spinal anesthesia and lumbar puncture procedures.
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実験的：Imran Technique
Participants underwent spinal anesthesia or lumbar puncture using the Imran Technique, a novel ergonomic positioning method designed to improve lumbar flexion, operator ergonomics, and procedural access.
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A novel ergonomic patient positioning technique for spinal anesthesia and lumbar puncture involving lateral operator positioning and assisted lumbar flexion to improve procedural access and success.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
First Attempt Procedural Success
時間枠：During the procedure (up to 30 minutes)
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Successful spinal anesthesia or lumbar puncture achieved with a single skin puncture on the first attempt.
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During the procedure (up to 30 minutes)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Procedural Time
時間枠：During the procedure (up to 30 minutes)
|
Total time required from patient positioning to successful completion of spinal anesthesia or lumbar puncture.
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During the procedure (up to 30 minutes)
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Number of Needle Attempts
時間枠：During the procedure
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Total number of skin puncture attempts required to successfully complete the procedure.
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During the procedure
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Needle Redirections
時間枠：During the procedure
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Number of needle redirections required during spinal anesthesia or lumbar puncture.
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During the procedure
|
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Intervertebral Space Changes
時間枠：During the procedure
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Number of intervertebral space changes required to successfully complete the procedure.
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During the procedure
|
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Overall Procedural Success
時間枠：During the procedure (up to 30 minutes)
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Successful completion of spinal anesthesia or lumbar puncture regardless of the number of attempts required.
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During the procedure (up to 30 minutes)
|
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Patient Comfort Assessed Using a 0-10 Numeric Rating Scale (NRS)
時間枠：During the procedure
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Participant comfort during positioning and spinal anesthesia/lumbar puncture was assessed using a 0-10 Numeric Rating Scale, where lower scores indicate greater comfort.
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During the procedure
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Ability to Maintain Position Assessed Using an Investigator-Defined 3-Category Scale
時間枠：During the procedure
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Participant ability to maintain the assigned procedural position was assessed using an investigator-defined 3-category scale: Easy, Moderate, or Difficult.
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During the procedure
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Operator Strain Assessed Using an Investigator-Defined 4-Category Ergonomic Scale
時間枠：During the procedure
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Operator physical strain during the procedure was assessed using an investigator-defined 4-category scale: None, Mild, Moderate, or Severe.
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During the procedure
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Accessibility of Intervertebral Space Assessed Using an Investigator-Defined 3-Category Operator Rating Scale
時間枠：During the procedure
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Accessibility of the intervertebral space was assessed by the operator using an investigator-defined 3-category scale: Easy, Acceptable, or Difficult.
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During the procedure
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Procedure-Related Complications
時間枠：uring the procedure and immediately after procedure (up to 1 hour)
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Occurrence of procedure-related events including paresthesia, bloody tap, hypotension, bradycardia, or procedural failure.
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uring the procedure and immediately after procedure (up to 1 hour)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Imran Ul Haq, MBBS, FCPS、Wah Medical College (NUMS) / POF Hospital Wah Cantt, Pakistan
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月2日
一次修了 (実際)
2026年3月31日
研究の完了 (実際)
2026年3月31日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月3日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- WMC-IRB-157-2026
- IRB Approval Number (その他の識別子：TMU-JIRB N202410073)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Individual participant data that underlie the results reported in the published article, after de-identification.
IPD 共有時間枠
Beginning 1 year after publication
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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