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A study done in patients who have undergone diagnostic cardiac catheterization that determines the influence of two different positions- elevating the head end of bed and lying down straight on bed during the post procedure period, on patient perception of back pain and bleeding complications.

A randomized controlled clinical trial comparing elevated bed position to the standard supine position, in terms of back pain and vascular access-site complications, in patients undergoing diagnostic cardiac catheterization.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/06/001791
Enrollment
80
Registered
2011-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Incidence and intensity of Back pain

Interventions

Intervention1: Head end elevation of bed: 30&deg
head end elevation in the first hour. Thereafter, 30&deg
-60&deg
elevation over the next 5 hours depending on the patient comfort. Control Intervention1: The Standard Supine Bed Position : The Patients Will Be Assigned the standard Supine Bed Position For 6 Hours.

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients above 18 years of age Elective diagnostic cardiac catheterization

Exclusion criteria

Exclusion criteria: Patients with history of back pain before the procedure, Non femoral approach, Patients with known bleeding disorders, Patients on oral anticoagulation continued to within 4 days of the procedure, Patients on parenteral anticoagulation prior to the procedure, Blood pressure >180/110 mm of Hg immediately prior to catheterization, Planned use of catheters other than 6F for arterial and 6F/ 7F for venous access, Patients not consenting to participate in the study.

Design outcomes

Primary

MeasureTime frame
The Occurrence Of Self-Reported Back Pain. Timepoint: The Outcome Is Observed At 5 Different Timepoints. 1. Immediately On Patient's Arrival To Ward. 2. At 2 Hours Of The Intervention. 3. At 4 Hours Of The Intervention. 4. At 6 Hours Of The Intervention. 5. At Discharge Of The Patient.—

Secondary

MeasureTime frame
1. Proportion Of Patients Reporting Moderate Or Severe Back Pain (Score more than or equal to 5 On The Numerical Pain Rating Scale).Timepoint: 1. Immediately On Arrival To Ward. 2. At 2 Hours Of The Intervention. 3. At 4 Hours Of The Intervention. 4. At 6 Hours of The Intervention. 5. At Discharge Of The Patient. ;The secondary safety outcome is the occurrence of vascular complications.Timepoint: 1. Immediately On Arrival To Ward. 2. At 2 Hours Of The Intervention. 3. At 4 Hours Of The Intervention. 4. At 6 Hours of The Intervention. 5. At Discharge Of The Patient.—

Countries

India

Contacts

Public ContactRachel Andrews

All India Institute of Medical Sciences

sujabaily@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026